Fresenius USA, Inc., et al.; Proposal To Withdraw Approval of 249 Abbreviated New Drug Applications; Opportunity for a Hearing, 1160-1167 [2020-00120]
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directs, and conducts the regional
operations of the agency; (3) provides
liaison, technical advice, and
consultation to the EPA, other federal,
tribal, state, and local agencies, private
organizations, community groups, and
individuals on eliminating or mitigating
public health problems resulting from
the release of hazardous substances into
the environment; (4) conducts and
evaluates exposure pathways analyses
and other exposure screening analyses
to identify impacted communities, to
include exposure investigations
(biologic sampling, personal monitoring,
etc.), and related environmental
assessments, as appropriate; (5) issues
public health advisories when a release
or threatened release of a toxic
substance poses an imminent health
hazard; (6) provides technical support
and field presence for routine
emergency and disaster response as
appropriate; (7) engages with regional
partners to accomplish special programs
that promote environmental health; (8)
provides scientific expertise in
environmental epidemiology; (9)
designs and conducts human health,
including epidemiologic, studies to
evaluate the association between
exposure to hazardous substances and
adverse health effects; (10) provides
expert medical and environmental
epidemiologic consultation; and (11)
implements extramural research
programs that involve human health
investigations.
• Office of Capacity Development and
Applied Prevention Science (JAAQD).
(1) Builds capabilities by translating
science into tools and actions that
individuals, communities, and
organizations apply to identify, reduce,
or prevent health effects from exposures
to hazardous substances; (2) coordinates
and conducts training, community
engagement, and system development
that addresses internal and external
needs as well as builds capacity of endusers; (3) develops best practices, tools,
and strategies for engaging with
communities, and providing community
engagement consultation to internal
ATSDR partners (e.g., health educators);
(4) conducts grant management, project
officers’ activities, and builds capacity
development through strategy
development, monitoring, and training;
(5) serves as an incubator for new
preventions, interventions, and
implementation science; supports
testing, development, and material
design for community and health
professional audiences; (6) designs and
standardizes intervention initiatives for
community audiences, evaluating
intervention design methods, and
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designing education campaigns; (7)
designs and standardize intervention
initiatives for health professionals,
evaluating intervention design methods,
and promoting environmental health
content within clinical education
programs; (8) designs, reviews and
evaluates the scientific accuracy and
clarity of health education materials; (9)
informs and promotes integration of
environmental health content within
clinical education programs (e.g.,
coursework, clinical rotations, and
primary care residency programs) and
environmental medicine practice; (10)
identifies and cultivates partnerships
with academic and professional
organizations to encourage uptake of
environmental public health awareness
curricula and career tracks; (11)
develops community/population and
clinical intervention initiatives to
reduce risk factors associated with
environmental exposures; (12) develops
integrated clinical support guidance for
patient care; (13) provides, promotes,
and/or implements ATSDR-approved
tools and training to partners (both
internal [e.g., health educators] and
external [e.g., state partners]) so that
they can effectively engage communities
using a standardized approach; (14)
provides evaluation guidance and
facilitates evaluation feedback loops
related to ATSDR intervention
initiatives, guidance materials, and
support tools for continuous quality
improvement and effectiveness of grantsupported work; (15) implements
ATSDR’s Site-Specific Cooperative
Agreement Program; (16) plans,
prepares, and executes appropriate
community involvement and health
educational strategies/activities/
programs for communities affected or
potentially affected by toxic substances
released into the environment; (17)
develops and tests metrics that could be
used for public health surveillance or
evaluation of intervention effectiveness;
and (18) partners with relevant internal
and external stakeholders to incorporate
prevention strategies into existing
programs, policies, and practices.
IV. Delegations of Authority: All
delegations and redelegations of
authority made to officials and
employees of affected organizational
components will continue in them or
their successors pending further
redelegation, provided they are
consistent with this reorganization.
(Authority: 44 U.S.C. 3101)
Alex M. Azar II,
Secretary.
[FR Doc. 2020–00181 Filed 1–8–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–5254]
Fresenius USA, Inc., et al.; Proposal To
Withdraw Approval of 249 Abbreviated
New Drug Applications; Opportunity
for a Hearing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA or Agency)
Center for Drug Evaluation and Research
(CDER) is proposing to withdraw
approval of 249 abbreviated new drug
applications (ANDAs) from multiple
holders of those ANDAs and is
announcing an opportunity for the
ANDA holders to request a hearing on
this proposal. The basis for the proposal
is that these ANDA holders have
repeatedly failed to file required annual
reports for those ANDAs.
DATES: The ANDA holders may submit
a request for a hearing by February 10,
2020. Submit all data, information, and
analyses upon which the request for a
hearing relies by March 9, 2020. Submit
electronic or written comments by
March 9, 2020.
ADDRESSES: The request for a hearing
may be submitted by the ANDA holders
by either of the following methods:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments to
submit your request for a hearing.
Comments submitted electronically to
https://www.regulations.gov, including
any attachments to the request for a
hearing, will be posted to the docket
unchanged.
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• Because your request for a hearing
will be made public, you are solely
responsible for ensuring that your
request does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
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as a manufacturing process. The request
for a hearing must include the Docket
No. FDA–2019–N–5254 for ‘‘Fresenius
USA, Inc., et al.; Proposal To Withdraw
Approval of 249 ANDAs; Opportunity
for a Hearing.’’ The request for a hearing
will be placed in the docket and
publicly viewable at https://
www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4
p.m., Monday through Friday.
The ANDA holders may submit all
data and analyses upon which the
request for a hearing relies in the same
manner as the request for a hearing
except as follows:
• Confidential Submissions—To
submit any data analyses with
confidential information that you do not
wish to be made publicly available,
submit your data and analyses only as
a written/paper submission. You should
submit two copies total of all data and
analyses. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of any decisions on
this matter. The second copy, which
will have the claimed confidential
information redacted/blacked out, will
be available for public viewing and
posted on https://www.regulations.gov
or available at the Dockets Management
Staff between 9 a.m. and 4 p.m.,
Monday through Friday. Submit both
copies to the Dockets Management Staff.
Any information marked as
‘‘confidential’’ will not be disclosed
except in accordance with § 10.20 (21
CFR 10.20) and other applicable
disclosure law.
Comments Submitted by Other
Interested Parties: For all comments
submitted by other interested parties,
submit comments as follows:
lotter on DSKBCFDHB2PROD with NOTICES
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–N–5254 for ‘‘Fresenius USA, Inc.,
et al.; Proposal To Withdraw Approval
of 249 ANDAs; Opportunity for a
Hearing.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
1161
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with § 10.20 and
other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–7920, Martha.Nguyen@fda.hhs.gov.
The
holders of approved ANDAs to market
new drugs for human use are required
to submit annual reports to FDA
concerning each of their approved
ANDAs under §§ 314.81 and 314.98 (21
CFR 314.81 and 314.98). The holders of
the approved ANDAs listed in the
following table have repeatedly failed to
submit the required annual reports and
have not responded to the Agency’s
request, sent by certified mail, for
submission of the reports.
SUPPLEMENTARY INFORMATION:
Application No.
Drug
Applicant
ANDA 020374 .........
Inpersol-LC/LM With Dextrose 1.5% (calcium chloride, dextrose, magnesium chloride, sodium chloride, sodium lactate) Intraperitoneal Solution, 18.4 milligrams (mg)/100
milliliters (mL); 1.5 grams (g)/100 mL; 5.08 mg/100 mL;
538 mg/100 mL; 448 mg/100 mL.
Fresenius USA, Inc., 2637 Shadelands Dr., Walnut Creek,
CA 94598.
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Application No.
Applicant
ANDA 040168 .........
Inpersol-LC/LM With Dextrose 2.5% (calcium chloride, dextrose, magnesium chloride, sodium chloride, sodium lactate) Intraperitoneal Solution, 18.4 mg/100 mL; 2.5 g/100
mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL.
Inpersol-LC/LM With Dextrose 3.5% (calcium chloride, dextrose, magnesium chloride, sodium chloride, sodium lactate) Intraperitoneal Solution, 18.4 mg/100 mL; 3.5 g/100
mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL.
Inpersol-LC/LM With Dextrose 4.25% (calcium chloride,
dextrose, magnesium chloride, sodium chloride, sodium
lactate) Intraperitoneal Solution, 18.4 mg/100 mL; 4.25 g/
100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100
mL.
Epinephrine and Lidocaine Hydrochloride (HCl) Injection,
0.01 mg/mL; 2% and 0.02 mg/mL; 2%.
Hydrocortisone and Acetic Acid Otic Solution USP, 1%/2%
ANDA 040192 .........
Prednisolone Syrup, 15 mg/5 mL ..........................................
ANDA 060074 .........
Penicillin G Potassium for Injection, 20,000,000 units/vial ...
ANDA 060131 .........
Tetracycline HCl Capsules ....................................................
ANDA 060461 .........
Neomycin Sulfate Ointment; Neomycin Sulfate and Hydrocortisone Acetate Ointment.
Humatin (paromomycin sulfate) Capsules USP, Equivalent
to (EQ) 250 mg base.
Penicillin G Potassium Powder .............................................
ANDA 040057 .........
ANDA 060521 .........
ANDA 060602 .........
ANDA 060627 .........
ANDA 060709 .........
ANDA 060724 .........
Tribiotic (polymyxin B sulfate, bacitracin, and neomycin sulfate) Ointment, 5000 units/400 units/5 mg.
Oleandomycin Injection .........................................................
ANDA 060769 .........
Pyocidin-HC (neomycin sulfate, polymyxin B sulfate, and
hydrocortisone) Otic Solution.
Tetracycline Syrup .................................................................
ANDA 060773 .........
ANDA 060870 .........
Tetracycline Syrup .................................................................
Oxytetracycline Injection ........................................................
ANDA 061034 .........
Lincomycin HCl Powder ........................................................
ANDA 061064 .........
Nystatin Ointment ..................................................................
ANDA 061087 .........
ANDA 061154 .........
ANDA 061209 .........
ANDA 061228 .........
Benzocaine, Oxytetracycline HCl, and Polymyxin B Sulfate
Otic Solution.
Hydrocortisone Acetate and Neomycin Sulfate Ointment .....
Bacitracin Ointment USP, 500 units/g ...................................
Griseofulvin Capsules ............................................................
ANDA 061483 .........
ANDA 061518 .........
Penicillin G Potassium Tablets ..............................................
Bacitracin Zinc Ointment .......................................................
ANDA 061519 .........
ANDA 061520 .........
ANDA 061632 .........
Bacitracin Zinc and Neomycin Sulfate Ointment ..................
Bacitracin Zinc and Neomycin Sulfate/Polymyxin B Sulfate
Ointment.
Bacitracin Zinc, Benzocaine, and Neomycin Sulfate/Polymyxin B Sulfate Ointment.
Penicillin V Potassium Tablets USP, EQ 250 mg base and
EQ 500 mg base.
Penicillin V Potassium for Oral Solution USP, EQ 125 mg
base/5 mL and EQ 250 mg base/5 mL.
Ampicillin Trihydrate Capsules ..............................................
Ampicillin for Oral Suspension USP, EQ 125 mg base/5 mL
and EQ 250 mg base/5 mL.
Ampicillin Capsules USP, EQ 250 mg base and EQ 500
mg base.
Ampicillin Trihydrate Capsules, 250 mg ................................
ANDA 061652 .........
Oxytetracycline Capsules ......................................................
ANDA 061674 .........
Penicillin V Potassium Tablets ..............................................
ANDA 061521 .........
ANDA 061528 .........
ANDA 061529 .........
ANDA 061532 .........
ANDA 061601 .........
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Drug
ANDA 061602 .........
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Eastman Kodak Co., 343 State St., Rochester, NY 14650.
Wockhardt EU Operations (Swiss) AG, c/o Morton Grove
Pharmaceuticals, Inc., 6451 West Main St., Morton
Grove, IL 60053.
WE Pharmaceuticals, Inc., 1142 D St., P.O. Box 1142, Ramona, CA 92065.
Pfizer Laboratories, Division of Pfizer, Inc., 235 East 42nd
St., New York, NY 10017.
Leiner Health Products, Inc., 901 East 233rd St., Carson,
CA 90745.
Ambix Laboratories, Division of Organics Corp. of America,
210 Orchard St., East Rutherford, NJ 07073.
Parkedale Pharmaceuticals, Inc., 501 5th St., Bristol, TN
37620.
John D. Copanos and Co., Inc., 6110 Robinwood Rd., Baltimore, MD 21225.
Ambix Laboratories, Division of Organics Corp. of America.
Roerig, Division of Pfizer, Inc., 235 East 42nd St., New
York, NY 10017.
Kasco-EFCO Laboratories, Inc., Cantiague Rock Rd.,
Hicksville, NY 11802.
West-Ward Pharmaceutical Corp., 465 Industrial Way
West, Eatontown, NJ 07724.
Leiner Health Products, Inc.
Proter S.p.A., c/o Richmar International, Inc., 1706 Birch
Rd., McLean, VA 22101.
Pharmacia and Upjohn Co., 7171 Portage Rd., Kalamazoo,
MI 49001.
Lederle Laboratories, Division of American Cyanamid Co.,
401 North Middletown Rd., Pearl River, NY 10965.
Pfizer Laboratories, Division of Pfizer, Inc.
Ambix Laboratories, Division of Organics Corp. of America.
Do.
Owen Laboratories, Division of Alcon Laboratories, 3737
Beltline Rd., Dallas, TX 75234.
Leiner Health Products, Inc.
Rexall Drug Co., 135 Chesterfield Industrial Blvd., Chesterfield, MO 63017.
Do.
Do.
Do.
American Antibiotics, Inc., 6110 Robinwood Rd., Baltimore,
MD 21225.
Do.
Leiner Health Products, Inc.
American Antibiotics, Inc.
Do.
Chromalloy Pharmaceuticals, Inc., 5353 Grosvenor Blvd.,
Los Angeles, CA 90066.
Warner-Lambert Co., 201 Tabor Rd., Morris Plains, NJ
07950.
Leiner Health Products, Inc.
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Application No.
Drug
Applicant
ANDA 061697 .........
Griseofulvin Capsules ............................................................
ANDA 061699 .........
Bacitracin Powder for Rx Compounding, 5,000,000 units/
bottle.
Tetracycline Syrup, 125 mg/5 mL .........................................
Watson Laboratories, Inc., 311 Bonnie Cir., Corona, CA
92880.
Apothekernes Laboratorium A.S., c/o AL Laboratories, Inc.,
1 Executive Dr., Fort Lee, NJ 07024.
AH Robins Co., 1211 Sherwood Ave., Richmond, VA
23220.
Warner-Lambert Co.
ANDA 061701 .........
ANDA 061725 .........
ANDA 061833 .........
Cyclopar (tetracycline HCl) Capsules USP, 250 mg and
500 mg.
Oxytetracycline HCl Capsules, 250 mg ................................
ANDA 061847 .........
Bleomycin Sulfate Injection ...................................................
ANDA 061857 .........
Penicillamine Powder ............................................................
ANDA 061903 .........
ANDA 061943 .........
Bacitracin Zinc and Polymyxin B Sulfate Ointment ..............
Chloramphenicol Ophthalmic Solution, 0.5% ........................
ANDA 062032 .........
ANDA 062215 .........
Erythromycin Stearate Tablets, EQ 250 mg base and EQ
500 mg base.
Tetracycline HCl Capsules, 250 mg ......................................
Tetracycline HCl Capsules, 250 mg ......................................
Cefaclor Capsules USP, EQ 250 mg base and EQ 500 mg
base.
Oxytetracycline HCl Capsules ...............................................
ANDA 062340 .........
Gentamicin Sulfate Injection ..................................................
ANDA 062467 .........
E-Solve 2 (erythromycin) Lotion, 2% ....................................
ANDA 062758 .........
ANDA 062869 .........
Eryzole (erythromycin ethylsuccinate and sulfisoxazole acetyl) Granules, EQ 200 mg base/5 mL; EQ 600 mg base/5
mL.
Cephalexin Capsules USP, EQ 500 mg base ......................
ANDA 062870 .........
ANDA 062944 .........
Cephalexin Capsules USP, EQ 250 mg base ......................
Clindamycin Phosphate Topical Solution USP, EQ 1% base
ANDA 070104 .........
Chlorhexidine Gluconate Topical Solution, 4% .....................
ANDA
ANDA
ANDA
ANDA
ANDA
.........
.........
.........
.........
.........
Constilac (lactulose) Solution, 10 g/15 mL ...........................
Ibu-tab 200 (ibuprofen) Tablets, 200 mg ..............................
Ibu-tab (ibuprofen) Tablets, 400 mg ......................................
Ibu-tab (ibuprofen) Tablets, 600 mg ......................................
Leucovorin Calcium Tablets, EQ 15 mg base ......................
ANDA 071139 .........
Trazodone HCl Tablets, 50 mg .............................................
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
Trazodone HCl Tablets, 100 mg ...........................................
Cholac (lactulose) Solution, 10 g/15 mL ...............................
Meclofenamate Sodium Capsules USP, 50 mg ....................
Meclofenamate Sodium Capsules USP, 100 mg ..................
Brian Care (chlorhexidine gluconate) Topical Solution, 4%
Clorazepate Dipotassium Capsules, 3.75 mg .......................
Clorazepate Dipotassium Capsules, 7.5 mg .........................
Clorazepate Dipotassium Capsules, 15 mg ..........................
Danazol Capsules USP, 200 mg ..........................................
Gen-Xene (clorazepate dipotassium) Tablets, 3.75 mg .......
Gen-Xene (clorazepate dipotassium) Tablets, 7.5 mg .........
Gen-Xene (clorazepate dipotassium) Tablets, 15 mg ..........
Oxazepam Capsules USP, 10 mg ........................................
Oxazepam Capsules USP, 15 mg ........................................
Oxazepam Capsules USP, 30 mg ........................................
Leucovorin Calcium Tablets, EQ 10 mg base ......................
Ibu-tab (ibuprofen) Tablets, 800 mg ......................................
Triamterene and Hydrochlorothiazide Tablets, 75 mg/50 mg
Maprotiline HCl Tablets USP, 25 mg ....................................
Maprotiline HCl Tablets USP, 50 mg ....................................
Maprotiline HCl Tablets USP, 75 mg ....................................
Metaproterenol Sulfate Inhalation Solution, 5% ....................
ANDA 072196 .........
Milophene (clomiphene citrate) Tablets, 50 mg ....................
ANDA 072255 .........
Microderm (chlorhexidine gluconate) Topical Solution, 4% ..
ANDA 062085 .........
ANDA 062175 .........
ANDA 062205 .........
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1163
071054
071057
071058
071059
071104
071140
071331
071362
071363
071419
071429
071430
071431
071569
071787
071788
071789
071955
071956
071957
071962
071965
072022
072129
072130
072131
072190
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Pliva, c/o Transtrade USA, Ltd., 515 Madison Ave., 4th
Floor East, New York, NY 10022.
Takasaki Plant, Nippon Kayaku Co., Ltd., 500 5th Ave.,
Suite 1726, New York, NY 10110.
Chemiewerk Homberg, c/o Wallace Laboratories, Cranbury,
NJ 08512.
Ambix Laboratories, Division of Organics Corp. of America.
Lederle Laboratories, Division of American Cyanamid Co.,
1 Cyanamid Plaza, Wayne, NJ 07470.
Warner-Lambert Co.
MM Mast and Co., 4152 Ruple Rd., Cleveland, OH 44121.
Warner-Lambert Co.
Ceph International Corp. c/o Mova Pharmaceutical Corp.,
State Rd #1 Jose Garrido St., Cagus, PR 00725.
Lederle Laboratories, Division of American Cyanamid Co.,
Pearl River, NY 10965–1215.
Pharmaceutical Specialist Association, 9852 Cowden St.,
Philadelphia, PA 19115.
Syosset Laboratories, Inc., 150 Eileen Way, Syosset, NY
11791.
Alra Laboratories, Inc., 3850 Clearview Ct., Gurnee, IL
60031.
Jerome Stevens Pharmaceuticals Inc., 60 DaVinci Dr., Bohemia, NY 11716.
Do.
BOCA Pharmacal, LLC., 3550 North West 126th Ave.,
Coral Springs, FL 33065.
Matrix Medical Corp., 1825 South 3730 West, Salt Lake
City, UT 84104.
Alra Laboratories, Inc.
Do.
Do.
Do.
Xanodyne Pharmacal, Inc., 7310 Turfway Rd., Suite 490,
Florence, KY 41042.
American Therapeutics, Inc., 89 Carlough Rd., Bohemia,
NY 11716.
Do.
Alra Laboratories, Inc.
American Therapeutics, Inc.
Do.
Soapco, Inc., P.O. Box 5490, Pleasanton, CA 94566.
American Therapeutics, Inc.
Do.
Do.
Do.
Alra Laboratories, Inc.
Do.
Do.
American Therapeutics, Inc.
Do.
Do.
Xanodyne Pharmacal, Inc.
Alra Laboratories, Inc.
American Therapeutics, Inc.
Do.
Do.
Do.
Wockhardt EU Operations (Swiss) AG, c/o Morton Grove
Pharmaceuticals, Inc.
Milex Products, Inc., 5915 Northwest Highway, Chicago, IL
60631.
Johnson and Johnson Medical, Inc., 2500 Arbrook Blvd.,
Arlington, TX 76014.
E:\FR\FM\09JAN1.SGM
09JAN1
1164
Federal Register / Vol. 85, No. 6 / Thursday, January 9, 2020 / Notices
Application No.
Drug
ANDA 072292 .........
.........
.........
.........
.........
.........
.........
.........
.........
Prevacare R (chlorhexidine gluconate) Topical Solution,
0.5%.
Microderm (chlorhexidine gluconate) Topical Sponge, 4% ..
Fenoprofen Calcium Capsules USP, 200 mg .......................
Fenoprofen Calcium Capsules USP, 300 mg .......................
Fenoprofen Calcium Tablets USP, 600 mg ..........................
Prazosin HCl Capsules USP, 1 mg ......................................
Prazosin HCl Capsules USP, 2 mg ......................................
Prazosin HCl Capsules USP, 5 mg ......................................
E–Z Scrub (chlorhexidine gluconate) Topical Sponge, 4% ..
ANDA 073535 .........
Piroxicam Capsules, 10 mg ..................................................
ANDA 074523 .........
Metromidol (metronidazole) Tablets, 250 mg and 500 mg ...
ANDA 074560 .........
ANDA 074702 .........
Flurbiprofen Tablets USP, 100 mg ........................................
Metaproterenol Sulfate Syrup, 10 mg/5 mL ..........................
ANDA 074881 .........
Iopamidol Injection, 41%, 51%, 61%, and 76% ....................
ANDA 074988 .........
ANDA 075260 .........
Aspirin, Caffeine, and Orphenadrine Citrate Tablets, 385
mg/30 mg/25 mg and 770 mg/60 mg/50 mg.
Prednisolone Sodium Phosphate Oral Solution, EQ 5 mg
base/5 mL.
Tretinoin Topical Solution, 0.05% .........................................
ANDA 075414 .........
Nifedipine Extended-Release Tablets, 90 mg .......................
ANDA 075507 .........
Ipratropium Bromide Inhalation Solution, 0.02% ...................
ANDA 075569 .........
ANDA 075586 .........
Thallous Chloride TL 201 Injection USP, 1 millicurie (mCi)/
mL.
Metaproterenol Sulfate Inhalation Solution, 0.4% and 0.6%
ANDA 075619 .........
Minoxidil Extra Strength (for Men) Topical Solution, 5% ......
ANDA 075766 .........
Calcitriol Injection, 1 microgram (mcg)/mL and 2 mcg/mL ...
ANDA 075941 .........
Strontium Chloride SR–89 Injection, 1 mCi/mL ....................
ANDA 077072 .........
Ipratropium Bromide Inhalation Solution, 0.02% ...................
ANDA 077218 .........
ANDA 080036 .........
ThyroShield (potassium iodide) Oral Solution USP, 65 mg/
mL.
Albuterol Sulfate Inhalation Solution, EQ 0.083% base .......
Sulfacel-15 (sulfacetamide sodium) Ophthalmic Solution,
15%.
Sosol (sulfisoxazole) Tablets, 500 mg ..................................
ANDA 080366 .........
ANDA 080380 .........
ANDA 080483 .........
Soxazole (sulfisoxazole) Tablets, 500 mg ............................
Bamate (meprobamate) Tablets, 200 mg and 400 mg .........
Hi-cor (hydrocortisone) Cream, 2.5% ....................................
ANDA 080492 .........
Reserpine Tablets, 0.1 mg and 0.25 mg ..............................
ANDA
ANDA
ANDA
ANDA
.........
.........
.........
.........
Dimenhydrinate Tablets, 50 mg ............................................
Diphenhydramine HCl Capsules, 25 mg and 50 mg ............
Reserpine Tablets, 0.1 mg and 0.25 mg ..............................
Diphenhydramine HCl Capsules, 50 mg ...............................
ANDA 080660 .........
.........
.........
.........
.........
Ocusulf (sulfacetamide sodium) Ophthalmic Solution, 10%
and 30%.
Diphenhydramine HCl Oral Solution, 12.5 mg/5 mL .............
Dimenhydrinate Oral Solution, 12.5 mg/4 mL .......................
Isoniazid Tablets, 100 mg .....................................................
Methscopolamine Bromide Tablets, 2.5 mg ..........................
ANDA 081145 .........
ANDA 083001 .........
Aspirin and Methocarbamol Tablets, 325 mg/400 mg ..........
Triamcinolone Acetonide Aerosol Foam Emulsion ...............
ANDA 083087 .........
ANDA 083088 .........
ANDA 083264 .........
Diphenhydramine HCl Capsules, 25 mg and 50 mg ............
Diphenhydramine HCl Elixir, 12.5 mg/5 mL ..........................
Pentobarbital Sodium Capsules, 100 mg ..............................
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
072295
072307
072308
072309
072782
072783
072784
073416
ANDA 075181 .........
lotter on DSKBCFDHB2PROD with NOTICES
ANDA 077569 .........
ANDA 080024 .........
ANDA
ANDA
ANDA
ANDA
080518
080519
080525
080592
080714
080715
080941
080970
VerDate Sep<11>2014
20:20 Jan 08, 2020
Jkt 250001
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Frm 00028
Applicant
Fmt 4703
Sfmt 4703
Do.
Do.
American Therapeutics, Inc.
Do.
Do.
Do.
Do.
Do.
Becton Dickinson Surgical System, 9450 South State St.,
Sandy, UT 84070.
Mutual Pharmaceutical Co., Inc., 1100 Orthodox St., Philadelphia, PA 19124.
Laboratorios Applicaciones Farmaceuticas S.A. de CV, c/o
Richard Hamer Association, Inc., P.O. Box 16598, Fort
Worth, TX 76162.
Theragen, Inc., 10 Lake Dr., East Windsor, NJ 08520.
Wockhardt EU Operations (Swiss) AG, c/o Morton Grove
Pharmaceuticals, Inc.
Cook Imaging Corp., 927 South Curry Pike, P.O. Box 3068,
Bloomington, IN 47403.
Jerome Stevens Pharmaceuticals, Inc.
WE Pharmaceuticals, Inc.
Wockhardt EU Operations (Swiss) AG, c/o Morton Grove
Pharmaceuticals, Inc.
Martec USA, LLC, 1800 North Topping Ave., Kansas City,
MO 64120.
Pharmascience, Inc., 10 Orchard Pl., Tenafly City, NJ
07670.
Trace Life Sciences, Inc., 2101 Shady Oaks, Denton, TX
76205.
Wockhardt EU Operations (Swiss) AG, c/o Morton Grove
Pharmaceuticals, Inc.
Avacor Products, LLC, 227 East 56th St., 3rd Floor, New
York, NY 10022.
Fresenius Medical Care North America, 95 Hayden Ave.,
Lexington, MA 02421.
Bio-Nucleonics, Inc., 1600 Market St., Suite 13200, Philadelphia, PA 19103.
Landela Pharmaceutical, 776 East Riverside Dr., Suite 150,
Eagle, ID 83616.
Arco Pharmaceuticals, LLC, 7605 Maryland Ave., St. Louis,
MO 63105.
Landela Pharmaceutical.
Optopics Laboratories Corp., P.O. Box 210, Fairton, NJ
08320.
MK Laboratories, Inc., 424 Grasmere Ave., Fairfield, CT
06430.
Alra Laboratories, Inc.
Do.
C and M Pharmacal, Inc., 1519 East 8 Mile Rd., Hazel
Park, MI 48030.
Marshall Pharmacal Corp., 89 Michael St., South Hackensack, NJ 07606.
Alra Laboratories, Inc.
Do.
MK Laboratories, Inc.
Valeant Pharmaceuticals International, One Enterprise,
Aliso Viejo, CA 92656.
Miza Pharmaceuticals USA, Inc., c/o Optopics Laboratories, 40 Main St., P.O. Box 210, Fairton, NJ 08320.
Alra Laboratories, Inc.
Do.
MK Laboratories, Inc.
Private Formulations, Inc., 460 Plainfield Ave., Edison, NJ
08818.
Jerome Stevens Pharmaceuticals, Inc.
Lederle Laboratories, Division of American Cyanamid Co.,
Pearl River, NY 10965–1215.
MK Laboratories, Inc.
Do.
Valeant Pharmaceuticals International.
E:\FR\FM\09JAN1.SGM
09JAN1
Federal Register / Vol. 85, No. 6 / Thursday, January 9, 2020 / Notices
Application No.
Drug
Applicant
ANDA 083286 .........
ANDA 083315 .........
Chlorpheniramine Maleate Tablets .......................................
Procaine HCl Injection, 1% and 2% ......................................
ANDA 083320 .........
ANDA 083389 .........
Acetazolamide Tablets, 250 mg ............................................
Epinephrine and Lidocaine HCl Injection, 0.01 mg/mL and
1%.
Epinephrine and Lidocaine HCl Injection, 0.01 mg/mL and
2%.
Vitamin A Palmitate Capsules, EQ 25,000 units base and
EQ 50,000 units base.
Butabarbital Sodium Tablets, 16.2 mg ..................................
Niacin Tablets, 500 mg .........................................................
Folic Acid Tablets, 1 mg ........................................................
Promethazine HCl Tablets, 25 mg ........................................
Dexamethasone Tablets, 0.75 mg ........................................
Marshall Pharmacal Corp.
Elkins Sinn Pharmaceutical Co., c/o ESI Lederle, 2
Esterbrook Ln., Cherry Hill, NJ 08003.
Alra Laboratories, Inc.
Dell Laboratories, Inc., 668 Front St., Teaneck, NJ 07666.
ANDA 083390 .........
ANDA 083457 .........
ANDA
ANDA
ANDA
ANDA
ANDA
083524
083525
083526
083658
083806
.........
.........
.........
.........
.........
ANDA 083827 .........
ANDA 083858 .........
ANDA 083863 .........
Pramine (imipramine HCl) Tablets, 10 mg, 25 mg, and 50
mg.
Butabarbital Sodium Tablets, 32.4 mg ..................................
Sulfisoxazole Cream ..............................................................
ANDA 084185 .........
Bethanechol Chloride Tablets, 10 mg ...................................
ANDA 084186 .........
ANDA 084188 .........
.........
.........
.........
.........
.........
Bethanechol Chloride Tablets, 25 mg ...................................
Myotonachol (bethanechol chloride) Tablets, 5 mg, 10 mg,
and 25 mg.
Cortisone Acetate Tablets, 25 mg .........................................
Prednisolone Tablets, 1 mg, 2.5 mg, and 5 mg ...................
Prednisone Tablets, 1 mg, 2.5 mg, and 5 mg ......................
Hydrochlorothiazide Tablets ..................................................
Pentobarbital Sodium Capsules, 100 mg ..............................
ANDA 084631 .........
ANDA 084687 .........
Quinidine Sulfate Tablets USP, 200 mg ...............................
Niacin Tablets, 500 mg .........................................................
ANDA 084714 .........
ANDA 084803 .........
Hydro-Reserp (hydrochlorothiazide and reserpine) Tablets,
50 mg/0.125 mg.
Lidocaton (epinephrine and lidocaine HCl) Injection, 0.01
mg/mL and 2%.
Chlorpromazine HCl Tablets, 10 mg .....................................
ANDA 084872 .........
ANDA 084902 .........
Meclizine HCl Tablets, 25 mg ...............................................
Promethacon (promethazine HCl) Suppository, 50 mg ........
ANDA 084931 .........
Methamphetamine HCl Tablets, 5 mg and 10 mg ................
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
084933
084977
085009
085039
085040
085041
085042
085044
085075
.........
.........
.........
.........
.........
.........
.........
.........
.........
ANDA
ANDA
ANDA
ANDA
085107
085108
085125
085217
.........
.........
.........
.........
ANDA 085235 .........
Diethylstilbestrol Tablets, 1 mg .............................................
Halothane Inhalation, 99.99% ...............................................
Lygen (chlordiazepoxide HCl) Capsules, 10 mg ...................
Folic Acid Tablets USP, 1 mg ...............................................
Isoniazid Tablets USP, 100 mg .............................................
Meclizine HCl Tablets, 25 mg ...............................................
Methocarbamol Tablets USP, 500 mg ..................................
Reserpine Tablets USP, 0.25 mg .........................................
Aerolate III (theophylline) Extended-Release Capsules, 65
mg.
Aerolate JR (theophylline) Extended-Release Capsules,
130 mg..
Aerolate SR (theophylline) Extended-Release Capsules,
260 mg..
Lygen (chlordiazepoxide HCl) Capsules, 5 mg .....................
Lygen (chlordiazepoxide HCl) Capsules, 25 mg ...................
Methyltestosterone Sublingual Tablets, 10 mg .....................
Acetaminophen and Codeine Phosphate Tablets, 325 mg/
30 mg.
Chlordiazepoxide HCl Capsules ............................................
ANDA
ANDA
ANDA
ANDA
.........
.........
.........
.........
Chlordiazepoxide HCl Capsules ............................................
Meclizine HCl Tablets, 25 mg ...............................................
Meclizine HCl Tablets, 12.5 mg ............................................
Hydrocortisone Lotion, 0.5% and 1% ....................................
ANDA 085383 .........
Butabarbital Sodium Elixir, 30 mg/5 mL ................................
ANDA
ANDA
ANDA
ANDA
ANDA
084246
084439
084440
084494
084590
ANDA 084729 .........
lotter on DSKBCFDHB2PROD with NOTICES
1165
085236
085252
085253
085282
VerDate Sep<11>2014
20:20 Jan 08, 2020
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Fmt 4703
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Do.
MK Laboratories, Inc.
Marshall Pharmacal Corp.
MK Laboratories, Inc.
Do.
Private Formulations, Inc.
Phoenix Laboratories, Inc., 175 Lauman Ln., East Hicksville, NY 11801.
Alra Laboratories, Inc.
Marshall Pharmacal Corp.
Holland Rantos Co., Inc., P.O. Box 385, Piscataway, NJ
08854.
Wendt Laboratories, Inc., 200 West Beaver, P.O. Box 128,
Belle Plaine, MN 56011.
Do.
Glenwood, Inc., 83 North Summit St., P.O. Box 518,
Tenafly, NJ 07670.
Everylife, 2021 15th Ave., West Seattle, WA 98119.
Do.
Do.
West-Ward Pharmaceutical Corp.
Anabolic, Inc., 1835 East Cheyenne Rd., Colorado Springs,
CO 80905.
Sandoz, Inc., 4700 Eon Dr., Wilson, NC 27893.
Zzeon Pharmaceuticals, Ltd., Jamboree at Kevin, Irvine,
CA 92705,
ABC Holding Corp., P.O. Box 307, 70945 Van Dyke Ave.,
Romeo, MI 48065.
Pharmaton, Ltd., c/o Bass Ullmna and Lustigman, 747 3rd
Ave., New York, NY 10017.
Lederle Laboratories, Division of American Cyanamid Co.,
Pearl River, NY 10965–1215.
CM Bundy Co., 2055 Reading Rd., Cincinnati, OH 45205.
Polymedica Industries, Inc., 2 Constitution Way, Woburn,
MA 01801.
Rexar Pharmacal, 396 Rockaway Ave., Valley Stream, NY
11581.
West-Ward Pharmaceutical Corp.
BH Chemicals, Inc., 500 5th Ave., New York, NY 10036.
Alra Laboratories, Inc.
Wendt Laboratories, Inc.
Do.
Do.
Do.
Do.
Fleming and Co. Pharmaceuticals, Inc., 1600 Fenton Park
Dr., Fenton, MO 63026.
Alra Laboratories, Inc.
Do.
Tablicaps, Inc., P.O. Box 5555, Franklinville, NJ 08322.
Everylife.
Abbott Laboratories, Pharmaceutical Products Division, 100
Abbott Park Rd., Abbott Park, IL 60064.
Do.
ABC Holding Corp.
Do.
Mericon Industries, Inc., 8819 North Pioneer Rd., Peoria, IL
61615.
Wockhardt EU Operations (Swiss) AG, c/o Morton Grove
Pharmaceuticals, Inc.
E:\FR\FM\09JAN1.SGM
09JAN1
1166
Federal Register / Vol. 85, No. 6 / Thursday, January 9, 2020 / Notices
Application No.
Drug
Applicant
.........
.........
.........
.........
.........
.........
Phentermine HCl Capsules, 30 mg .......................................
Cam-Metrazine (phendimetrazine tartrate) Tablets, 35 mg ..
Phenazine-35 (phendimetrazine tartrate) Tablets, 35 mg ....
Butabarbital Sodium Tablets, 30 mg .....................................
Chlorothiazide Tablets, 250 mg ............................................
Meclizine Hydrochloride Chewable Tablets ..........................
ANDA 085638 .........
ANDA 085882 .........
Codeine, Aspirin, APAP Formula No. 4 (codeine phosphate, aspirin, and acetaminophen) Capsules, 60 mg/180
mg/150 mg.
Codeine, Aspirin, APAP Formula No. 3 (codeine phosphate, aspirin, and acetaminophen) Capsules, 30 mg/180
mg/150 mg.
Codeine, Aspirin, APAP Formula No. 2 (codeine phosphate, aspirin, and acetaminophen) Capsules, 15 mg/180
mg/150 mg.
Hydrochlorothiazide Tablets, 50 mg ......................................
Cam-Metrazine (phendimetrazine tartrate) Tablets, 35 mg ..
Atropine Sulfate and Diphenoxylate HCl Tablets, 0.025 mg/
2.5 mg.
Duvoid (bethanechol chloride) Tablets, 50 mg .....................
ABC Holding Corp.
Do.
Do.
CM Bundy Co.
ABC Holding Corp.
Camall Co., Inc., 60950 Van Dyke Ave., P.O. Box 218,
Washington, MI 48094.
Scherer Laboratories, Inc., 2301 Ohio Dr., Suite 234,
Plano, TX 75093.
ANDA
ANDA
ANDA
ANDA
085888
085891
085895
086008
.........
.........
.........
.........
Brompheniramine Maleate Tablets .......................................
Meclizine HCl Tablets, 25 mg ...............................................
Secobarbital Sodium Capsules, 100 mg ...............................
Hydrocortisone and Urea Cream, 1%/10% ...........................
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
086077
086079
086080
086141
086260
086262
086263
086271
086272
086498
086499
086500
086501
086502
086503
086511
086516
086550
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
Nitrofurazone Ointment, 0.2% ...............................................
Hydrocortisone Ointment, 1% ...............................................
Hydrocortisone Cream, 1% ...................................................
Tolbutamide Tablets, 500 mg ................................................
Ona-Mast (phentermine HCl) Tablets, 8 mg .........................
Duvoid (bethanechol chloride) Tablets, 10 mg .....................
Duvoid (bethanechol chloride) Tablets, 25 mg .....................
Hydrocortisone Cream, 2.5% ................................................
Hydrocortisone Ointment, 2.5% ............................................
Amitriptyline HCl Tablets, 10 mg ...........................................
Amitriptyline HCl Tablets, 50 mg ...........................................
Amitriptyline HCl Tablets, 150 mg .........................................
Amitriptyline HCl Tablets, 100 mg .........................................
Amitriptyline HCl Tablets, 25 mg ...........................................
Amitriptyline HCl Tablets, 75 mg ...........................................
Ona-Mast (phentermine HCl) Capsules, 30 mg ....................
Ona-Mast (phentermine HCl) Capsules, 30 mg ....................
X-Trozine (phendimetrazine tartrate) Tablets, 35 mg ...........
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
086551
086552
086553
086554
086735
086748
.........
.........
.........
.........
.........
.........
X-Trozine (phendimetrazine tartrate) Tablets, 35 mg ...........
X-Trozine (phendimetrazine tartrate) Tablets, 35 mg ...........
X-Trozine (phendimetrazine tartrate) Tablets, 35 mg ...........
X-Trozine (phendimetrazine tartrate) Tablets, 35 mg ...........
Phentermine HCl Capsules, 15 mg .......................................
Theophylline Elixir, 80 mg/15 mL ..........................................
ANDA
ANDA
ANDA
ANDA
086766
087081
087226
087371
.........
.........
.........
.........
Nitrofurazone Ointment, 0.2% ...............................................
Nitrofurazone Topical Solution, 0.2% ....................................
Phentermine HCl Capsules, 30 mg .......................................
X-Trozine L.A. (phendimetrazine tartrate) Extended-Release Capsules, 105 mg.
Aminophylline Injection, 25 mg/mL .......................................
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
085411
085511
085512
085550
085569
085587
ANDA 085639 .........
ANDA 085640 .........
ANDA 085672 .........
ANDA 085756 .........
ANDA 085766 .........
ANDA 087392 .........
ANDA 087394 .........
ANDA 087442 .........
ANDA 087636 .........
X-Trozine (phendimetrazine tartrate) Capsules, 35 mg ........
Neosar (cyclophosphamide) for Injection, 100 mg/vial, 200
mg/vial, 500 mg/vial, 1 g/vial, and 2 g/vial.
Melfiat-105 (phendimetrazine tartrate) Extended-Release
Capsules, 105 mg.
Tropicamide Ophthalmic Solution, 0.5% ...............................
ANDA
ANDA
ANDA
ANDA
ANDA
Tropicamide Ophthalmic Solution, 1% ..................................
Paracaine (proparacaine HCl) Ophthalmic Solution, 0.5% ...
Oby-Trim (phentermine HCl) Capsules, 30 mg ....................
Triamcinolone Acetonide Cream, 0.025% .............................
Sodium Polystyrene Sulfonate USP Powder, 453.6 g/bottle
lotter on DSKBCFDHB2PROD with NOTICES
ANDA 087487 .........
087637
087681
087764
087932
088786
VerDate Sep<11>2014
.........
.........
.........
.........
.........
20:20 Jan 08, 2020
Jkt 250001
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Frm 00030
Fmt 4703
Sfmt 4703
Do.
Do.
ABC Holding Corp.
Camall Co., Inc.
Private Formulations, Inc.
Chartwell RX Sciences, LLC, 77 Brenner Dr., Congers, NY
10920.
Leiner Health Products, Inc.
Anabolic, Inc.
Everylife.
Bioglan Laboratories, Ltd., 450 Hilltop Rd., Riegelsville, PA
18077.
Ambix Laboratories, Division of Organics Corp. of America.
Do.
Do.
Alra Laboratories, Inc.
MM Mast and Co.
Chartwell RX Sciences, LLC.
Do.
Ambix Laboratories, Division of Organics Corp. of America.
Do.
Alra Laboratories, Inc.
Do.
Do.
Do.
Do.
Do.
MM Mast and Co.
Do.
Shire Richwood, Inc., 7900 Tanners Gate Dr., Suite 200,
Florence, KY 41042.
Do.
Do.
Do.
Do.
Camall Co., Inc.
Wockhardt EU Operations (Swiss) AG, c/o Morton Grove
Pharmaceuticals, Inc.
Wendt Laboratories, Inc.
Do.
Camall Co., Inc.
Shire Richwood, Inc.
Pharma Serve, Inc., Subsidiary of Torigian Laboratories,
218–20 98th Ave., Queens Village, NY 11429.
Shire Richwood, Inc.
Bedford Laboratories, Division of Ben Venue Laboratories,
Inc., 300 Northfield Rd., Bedford, OH 44146.
Numark Laboratories, Inc., 75 Mayfield Ave., Edison, NJ
08837.
Miza Pharmaceuticals USA, Inc., c/o Optopics Laboratories.
Do.
Optopics Laboratories Corp.
Shire Richwood, Inc.
Ambix Laboratories, Division of Organics Corp. of America.
Wockhardt EU Operations (Swiss) AG, c/o Morton Grove
Pharmaceuticals, Inc.
E:\FR\FM\09JAN1.SGM
09JAN1
Federal Register / Vol. 85, No. 6 / Thursday, January 9, 2020 / Notices
Application No.
Drug
ANDA 088897 .........
ANDA 089514 .........
Promethazine VC Plain (phenylephrine HCl and
promethazine HCl) Syrup, 5 mg/5 mL and 6.25 mg/5 mL.
Aerolate (theophylline) Oral Solution, 150 mg/15 mL ...........
Methocarbamol Tablets USP, 500 mg ..................................
Methocarbamol Tablets USP, 750 mg ..................................
Acetaminophen and Codeine Phosphate Tablets USP, 300
mg/15 mg.
Acetaminophen and Codeine Phosphate Tablets USP, 300
mg/30 mg.
Acetaminophen and Codeine Phosphate Tablets USP, 300
mg/60 mg.
Trihexyphenidyl HCl Elixir, 2 mg/5 mL ..................................
ANDA 089726 .........
Prednisone Oral Solution, 5 mg/5 mL ...................................
ANDA 204472 .........
Fludeoxyglucose F–18 Injection USP, 20–300 mCi/mL .......
ANDA 204517 .........
ANDA 204535 .........
Sodium Fluoride F–18 Injection, 10–200 mCi/mL .................
Ammonia N–13 Injection USP, 3.75–37.5 mCi/mL ...............
ANDA
ANDA
ANDA
ANDA
089141
089417
089418
089478
.........
.........
.........
.........
ANDA 089479 .........
lotter on DSKBCFDHB2PROD with NOTICES
ANDA 089480 .........
Therefore, under §§ 314.150(b)(1) and
314.200 (21 CFR 314.150(b)(1) and
314.200), notice is given to the holders
of the approved ANDAs listed in the
table and to all other interested persons
that the Director of CDER proposes to
issue an order under section 505(e) of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 355(e))
withdrawing approval of the ANDAs
and all amendments and supplements to
them on the grounds that the ANDA
holders have failed to submit reports
required under §§ 314.81 and 314.98.
In accordance with section 505 of the
FD&C Act and part 314 (21 CFR part
314), the ANDA holders are hereby
provided an opportunity for a hearing to
show why the applications listed
previously should not be withdrawn
and an opportunity to raise, for an
administrative determination, all issues
relating to the legal status of the drug
products covered by these ANDAs.
An ANDA holder who decides to seek
a hearing must file the following: (1) A
written notice of participation and
request for a hearing (see DATES and
ADDRESSES) and (2) the data,
information, and analyses relied on to
demonstrate that there is a genuine and
substantial issue of fact that requires a
hearing (see DATES and ADDRESSES). Any
other interested person may also submit
comments on this notice. The
procedures and requirements governing
this notice of opportunity for a hearing,
the notice of participation and request
for a hearing; the information and
analyses to justify a hearing, other
comments, and a grant or denial of a
hearing are contained in § 314.200 and
in 21 CFR part 12.
The failure of an ANDA holder to file
a timely written notice of participation
and request for a hearing, as required by
§ 314.200, constitutes an election by that
VerDate Sep<11>2014
20:20 Jan 08, 2020
Jkt 250001
Applicant
Do.
Fleming and Co. Pharmaceuticals, Inc.
American Therapeutics, Inc.
Do.
Do.
Do.
Do.
Pharmaceutical Ventures, Ltd., P.O. Box D3700, Pomona,
NY 10970.
Wockhardt EU Operations (Swiss) AG, c/o Morton Grove
Pharmaceuticals, Inc.
MIPS Cyclotron and Radiochemistry Facility, 1201 Welch
Rd., Rm. PS049, Stanford, CA 94305.
Do.
Do.
ANDA holder not to avail itself of the
opportunity for a hearing concerning
CDER’s proposal to withdraw approval
of the ANDAs and constitutes a waiver
of any contentions concerning the legal
status of the drug products. FDA will
then withdraw approval of the ANDAs,
and the drug products may not
thereafter be lawfully introduced or
delivered for introduction into interstate
commerce. Any new drug product
introduced or delivered for introduction
into interstate commerce without an
approved ANDA is subject to regulatory
action at any time.
A request for a hearing may not rest
upon mere allegations or denials but
must present specific facts showing that
there is a genuine and substantial issue
of fact that requires a hearing. If a
request for a hearing is not complete or
is not supported, the Commissioner of
Food and Drugs will enter summary
judgment against the person who
requests the hearing, making findings
and conclusions, and denying a hearing.
All submissions under this notice of
opportunity for a hearing must be filed
in four copies. Except for data and
information prohibited from public
disclosure under 21 U.S.C. 331(j) or 18
U.S.C. 1905, the submissions may be
seen at the Dockets Management Staff
(see ADDRESSES) between 9 a.m. and 4
p.m., Monday through Friday, and will
be posted to the docket at https://
www.regulations.gov.
This notice is issued under section
505(e) of the FD&C Act and under
authority delegated to the Director of
CDER by the Commissioner of Food and
Drugs.
PO 00000
Frm 00031
1167
Fmt 4703
Sfmt 4703
Dated: January 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–00120 Filed 1–8–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0797]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Human Tissue
Intended for Transplantation
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by February
10, 2020.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0302. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
E:\FR\FM\09JAN1.SGM
09JAN1
]]>Agencies
[Federal Register Volume 85, Number 6 (Thursday, January 9, 2020)]
[Notices]
[Pages 1160-1167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00120]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-5254]
Fresenius USA, Inc., et al.; Proposal To Withdraw Approval of 249
Abbreviated New Drug Applications; Opportunity for a Hearing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for
Drug Evaluation and Research (CDER) is proposing to withdraw approval
of 249 abbreviated new drug applications (ANDAs) from multiple holders
of those ANDAs and is announcing an opportunity for the ANDA holders to
request a hearing on this proposal. The basis for the proposal is that
these ANDA holders have repeatedly failed to file required annual
reports for those ANDAs.
DATES: The ANDA holders may submit a request for a hearing by February
10, 2020. Submit all data, information, and analyses upon which the
request for a hearing relies by March 9, 2020. Submit electronic or
written comments by March 9, 2020.
ADDRESSES: The request for a hearing may be submitted by the ANDA
holders by either of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments to submit your request
for a hearing. Comments submitted electronically to https://www.regulations.gov, including any attachments to the request for a
hearing, will be posted to the docket unchanged.
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Because your request for a hearing will be made public,
you are solely responsible for ensuring that your request does not
include any confidential information that you or a third party may not
wish to be posted, such as medical information, your or anyone else's
Social Security number, or confidential business information, such
[[Page 1161]]
as a manufacturing process. The request for a hearing must include the
Docket No. FDA-2019-N-5254 for ``Fresenius USA, Inc., et al.; Proposal
To Withdraw Approval of 249 ANDAs; Opportunity for a Hearing.'' The
request for a hearing will be placed in the docket and publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
The ANDA holders may submit all data and analyses upon which the
request for a hearing relies in the same manner as the request for a
hearing except as follows:
Confidential Submissions--To submit any data analyses with
confidential information that you do not wish to be made publicly
available, submit your data and analyses only as a written/paper
submission. You should submit two copies total of all data and
analyses. One copy will include the information you claim to be
confidential with a heading or cover note that states ``THIS DOCUMENT
CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy,
including the claimed confidential information, in its consideration of
any decisions on this matter. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov
or available at the Dockets Management Staff between 9 a.m. and 4 p.m.,
Monday through Friday. Submit both copies to the Dockets Management
Staff. Any information marked as ``confidential'' will not be disclosed
except in accordance with Sec. 10.20 (21 CFR 10.20) and other
applicable disclosure law.
Comments Submitted by Other Interested Parties: For all comments
submitted by other interested parties, submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2019-N-5254 for ``Fresenius USA, Inc., et al.; Proposal To Withdraw
Approval of 249 ANDAs; Opportunity for a Hearing.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec. 10.20 and other applicable
disclosure law. For more information about FDA's posting of comments to
public dockets, see 80 FR 56469, September 18, 2015, or access the
information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-7920, [email protected].
SUPPLEMENTARY INFORMATION: The holders of approved ANDAs to market new
drugs for human use are required to submit annual reports to FDA
concerning each of their approved ANDAs under Sec. Sec. 314.81 and
314.98 (21 CFR 314.81 and 314.98). The holders of the approved ANDAs
listed in the following table have repeatedly failed to submit the
required annual reports and have not responded to the Agency's request,
sent by certified mail, for submission of the reports.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
ANDA 020374............... Inpersol-LC/LM With Fresenius USA, Inc.,
Dextrose 1.5% 2637 Shadelands Dr.,
(calcium chloride, Walnut Creek, CA
dextrose, magnesium 94598.
chloride, sodium
chloride, sodium
lactate)
Intraperitoneal
Solution, 18.4
milligrams (mg)/100
milliliters (mL);
1.5 grams (g)/100
mL; 5.08 mg/100 mL;
538 mg/100 mL; 448
mg/100 mL.
[[Page 1162]]
Inpersol-LC/LM With
Dextrose 2.5%
(calcium chloride,
dextrose, magnesium
chloride, sodium
chloride, sodium
lactate)
Intraperitoneal
Solution, 18.4 mg/
100 mL; 2.5 g/100
mL; 5.08 mg/100 mL;
538 mg/100 mL; 448
mg/100 mL.
Inpersol-LC/LM With
Dextrose 3.5%
(calcium chloride,
dextrose, magnesium
chloride, sodium
chloride, sodium
lactate)
Intraperitoneal
Solution, 18.4 mg/
100 mL; 3.5 g/100
mL; 5.08 mg/100 mL;
538 mg/100 mL; 448
mg/100 mL.
Inpersol-LC/LM With
Dextrose 4.25%
(calcium chloride,
dextrose, magnesium
chloride, sodium
chloride, sodium
lactate)
Intraperitoneal
Solution, 18.4 mg/
100 mL; 4.25 g/100
mL; 5.08 mg/100 mL;
538 mg/100 mL; 448
mg/100 mL.
ANDA 040057............... Epinephrine and Eastman Kodak Co.,
Lidocaine 343 State St.,
Hydrochloride (HCl) Rochester, NY 14650.
Injection, 0.01 mg/
mL; 2% and 0.02 mg/
mL; 2%.
ANDA 040168............... Hydrocortisone and Wockhardt EU
Acetic Acid Otic Operations (Swiss)
Solution USP, 1%/2%. AG, c/o Morton Grove
Pharmaceuticals,
Inc., 6451 West Main
St., Morton Grove,
IL 60053.
ANDA 040192............... Prednisolone Syrup, WE Pharmaceuticals,
15 mg/5 mL. Inc., 1142 D St.,
P.O. Box 1142,
Ramona, CA 92065.
ANDA 060074............... Penicillin G Pfizer Laboratories,
Potassium for Division of Pfizer,
Injection, Inc., 235 East 42nd
20,000,000 units/ St., New York, NY
vial. 10017.
ANDA 060131............... Tetracycline HCl Leiner Health
Capsules. Products, Inc., 901
East 233rd St.,
Carson, CA 90745.
ANDA 060461............... Neomycin Sulfate Ambix Laboratories,
Ointment; Neomycin Division of Organics
Sulfate and Corp. of America,
Hydrocortisone 210 Orchard St.,
Acetate Ointment. East Rutherford, NJ
07073.
ANDA 060521............... Humatin (paromomycin Parkedale
sulfate) Capsules Pharmaceuticals,
USP, Equivalent to Inc., 501 5th St.,
(EQ) 250 mg base. Bristol, TN 37620.
ANDA 060602............... Penicillin G John D. Copanos and
Potassium Powder. Co., Inc., 6110
Robinwood Rd.,
Baltimore, MD 21225.
ANDA 060627............... Tribiotic (polymyxin Ambix Laboratories,
B sulfate, Division of Organics
bacitracin, and Corp. of America.
neomycin sulfate)
Ointment, 5000 units/
400 units/5 mg.
ANDA 060709............... Oleandomycin Roerig, Division of
Injection. Pfizer, Inc., 235
East 42nd St., New
York, NY 10017.
ANDA 060724............... Pyocidin-HC (neomycin Kasco-EFCO
sulfate, polymyxin B Laboratories, Inc.,
sulfate, and Cantiague Rock Rd.,
hydrocortisone) Otic Hicksville, NY
Solution. 11802.
ANDA 060769............... Tetracycline Syrup... West-Ward
Pharmaceutical
Corp., 465
Industrial Way West,
Eatontown, NJ 07724.
ANDA 060773............... Tetracycline Syrup... Leiner Health
Products, Inc.
ANDA 060870............... Oxytetracycline Proter S.p.A., c/o
Injection. Richmar
International, Inc.,
1706 Birch Rd.,
McLean, VA 22101.
ANDA 061034............... Lincomycin HCl Powder Pharmacia and Upjohn
Co., 7171 Portage
Rd., Kalamazoo, MI
49001.
ANDA 061064............... Nystatin Ointment.... Lederle Laboratories,
Division of American
Cyanamid Co., 401
North Middletown
Rd., Pearl River, NY
10965.
ANDA 061087............... Benzocaine, Pfizer Laboratories,
Oxytetracycline HCl, Division of Pfizer,
and Polymyxin B Inc.
Sulfate Otic
Solution.
ANDA 061154............... Hydrocortisone Ambix Laboratories,
Acetate and Neomycin Division of Organics
Sulfate Ointment. Corp. of America.
ANDA 061209............... Bacitracin Ointment Do.
USP, 500 units/g.
ANDA 061228............... Griseofulvin Capsules Owen Laboratories,
Division of Alcon
Laboratories, 3737
Beltline Rd.,
Dallas, TX 75234.
ANDA 061483............... Penicillin G Leiner Health
Potassium Tablets. Products, Inc.
ANDA 061518............... Bacitracin Zinc Rexall Drug Co., 135
Ointment. Chesterfield
Industrial Blvd.,
Chesterfield, MO
63017.
ANDA 061519............... Bacitracin Zinc and Do.
Neomycin Sulfate
Ointment.
ANDA 061520............... Bacitracin Zinc and Do.
Neomycin Sulfate/
Polymyxin B Sulfate
Ointment.
ANDA 061521............... Bacitracin Zinc, Do.
Benzocaine, and
Neomycin Sulfate/
Polymyxin B Sulfate
Ointment.
ANDA 061528............... Penicillin V American Antibiotics,
Potassium Tablets Inc., 6110 Robinwood
USP, EQ 250 mg base Rd., Baltimore, MD
and EQ 500 mg base. 21225.
ANDA 061529............... Penicillin V Do.
Potassium for Oral
Solution USP, EQ 125
mg base/5 mL and EQ
250 mg base/5 mL.
ANDA 061532............... Ampicillin Trihydrate Leiner Health
Capsules. Products, Inc.
ANDA 061601............... Ampicillin for Oral American Antibiotics,
Suspension USP, EQ Inc.
125 mg base/5 mL and
EQ 250 mg base/5 mL.
ANDA 061602............... Ampicillin Capsules Do.
USP, EQ 250 mg base
and EQ 500 mg base.
ANDA 061632............... Ampicillin Trihydrate Chromalloy
Capsules, 250 mg. Pharmaceuticals,
Inc., 5353 Grosvenor
Blvd., Los Angeles,
CA 90066.
ANDA 061652............... Oxytetracycline Warner-Lambert Co.,
Capsules. 201 Tabor Rd.,
Morris Plains, NJ
07950.
ANDA 061674............... Penicillin V Leiner Health
Potassium Tablets. Products, Inc.
[[Page 1163]]
ANDA 061697............... Griseofulvin Capsules Watson Laboratories,
Inc., 311 Bonnie
Cir., Corona, CA
92880.
ANDA 061699............... Bacitracin Powder for Apothekernes
Rx Compounding, Laboratorium A.S., c/
5,000,000 units/ o AL Laboratories,
bottle. Inc., 1 Executive
Dr., Fort Lee, NJ
07024.
ANDA 061701............... Tetracycline Syrup, AH Robins Co., 1211
125 mg/5 mL. Sherwood Ave.,
Richmond, VA 23220.
ANDA 061725............... Cyclopar Warner-Lambert Co.
(tetracycline HCl)
Capsules USP, 250 mg
and 500 mg.
ANDA 061833............... Oxytetracycline HCl Pliva, c/o Transtrade
Capsules, 250 mg. USA, Ltd., 515
Madison Ave., 4th
Floor East, New
York, NY 10022.
ANDA 061847............... Bleomycin Sulfate Takasaki Plant,
Injection. Nippon Kayaku Co.,
Ltd., 500 5th Ave.,
Suite 1726, New
York, NY 10110.
ANDA 061857............... Penicillamine Powder. Chemiewerk Homberg, c/
o Wallace
Laboratories,
Cranbury, NJ 08512.
ANDA 061903............... Bacitracin Zinc and Ambix Laboratories,
Polymyxin B Sulfate Division of Organics
Ointment. Corp. of America.
ANDA 061943............... Chloramphenicol Lederle Laboratories,
Ophthalmic Solution, Division of American
0.5%. Cyanamid Co., 1
Cyanamid Plaza,
Wayne, NJ 07470.
ANDA 062032............... Erythromycin Stearate Warner-Lambert Co.
Tablets, EQ 250 mg
base and EQ 500 mg
base.
ANDA 062085............... Tetracycline HCl MM Mast and Co., 4152
Capsules, 250 mg. Ruple Rd.,
Cleveland, OH 44121.
ANDA 062175............... Tetracycline HCl Warner-Lambert Co.
Capsules, 250 mg.
ANDA 062205............... Cefaclor Capsules Ceph International
USP, EQ 250 mg base Corp. c/o Mova
and EQ 500 mg base. Pharmaceutical
Corp., State Rd #1
Jose Garrido St.,
Cagus, PR 00725.
ANDA 062215............... Oxytetracycline HCl Lederle Laboratories,
Capsules. Division of American
Cyanamid Co., Pearl
River, NY 10965-
1215.
ANDA 062340............... Gentamicin Sulfate Pharmaceutical
Injection. Specialist
Association, 9852
Cowden St.,
Philadelphia, PA
19115.
ANDA 062467............... E-Solve 2 Syosset Laboratories,
(erythromycin) Inc., 150 Eileen
Lotion, 2%. Way, Syosset, NY
11791.
ANDA 062758............... Eryzole (erythromycin Alra Laboratories,
ethylsuccinate and Inc., 3850 Clearview
sulfisoxazole Ct., Gurnee, IL
acetyl) Granules, EQ 60031.
200 mg base/5 mL; EQ
600 mg base/5 mL.
ANDA 062869............... Cephalexin Capsules Jerome Stevens
USP, EQ 500 mg base. Pharmaceuticals
Inc., 60 DaVinci
Dr., Bohemia, NY
11716.
ANDA 062870............... Cephalexin Capsules Do.
USP, EQ 250 mg base.
ANDA 062944............... Clindamycin Phosphate BOCA Pharmacal, LLC.,
Topical Solution 3550 North West
USP, EQ 1% base. 126th Ave., Coral
Springs, FL 33065.
ANDA 070104............... Chlorhexidine Matrix Medical Corp.,
Gluconate Topical 1825 South 3730
Solution, 4%. West, Salt Lake
City, UT 84104.
ANDA 071054............... Constilac (lactulose) Alra Laboratories,
Solution, 10 g/15 mL. Inc.
ANDA 071057............... Ibu-tab 200 Do.
(ibuprofen) Tablets,
200 mg.
ANDA 071058............... Ibu-tab (ibuprofen) Do.
Tablets, 400 mg.
ANDA 071059............... Ibu-tab (ibuprofen) Do.
Tablets, 600 mg.
ANDA 071104............... Leucovorin Calcium Xanodyne Pharmacal,
Tablets, EQ 15 mg Inc., 7310 Turfway
base. Rd., Suite 490,
Florence, KY 41042.
ANDA 071139............... Trazodone HCl American
Tablets, 50 mg. Therapeutics, Inc.,
89 Carlough Rd.,
Bohemia, NY 11716.
ANDA 071140............... Trazodone HCl Do.
Tablets, 100 mg.
ANDA 071331............... Cholac (lactulose) Alra Laboratories,
Solution, 10 g/15 mL. Inc.
ANDA 071362............... Meclofenamate Sodium American
Capsules USP, 50 mg. Therapeutics, Inc.
ANDA 071363............... Meclofenamate Sodium Do.
Capsules USP, 100 mg.
ANDA 071419............... Brian Care Soapco, Inc., P.O.
(chlorhexidine Box 5490,
gluconate) Topical Pleasanton, CA
Solution, 4%. 94566.
ANDA 071429............... Clorazepate American
Dipotassium Therapeutics, Inc.
Capsules, 3.75 mg.
ANDA 071430............... Clorazepate Do.
Dipotassium
Capsules, 7.5 mg.
ANDA 071431............... Clorazepate Do.
Dipotassium
Capsules, 15 mg.
ANDA 071569............... Danazol Capsules USP, Do.
200 mg.
ANDA 071787............... Gen-Xene (clorazepate Alra Laboratories,
dipotassium) Inc.
Tablets, 3.75 mg.
ANDA 071788............... Gen-Xene (clorazepate Do.
dipotassium)
Tablets, 7.5 mg.
ANDA 071789............... Gen-Xene (clorazepate Do.
dipotassium)
Tablets, 15 mg.
ANDA 071955............... Oxazepam Capsules American
USP, 10 mg. Therapeutics, Inc.
ANDA 071956............... Oxazepam Capsules Do.
USP, 15 mg.
ANDA 071957............... Oxazepam Capsules Do.
USP, 30 mg.
ANDA 071962............... Leucovorin Calcium Xanodyne Pharmacal,
Tablets, EQ 10 mg Inc.
base.
ANDA 071965............... Ibu-tab (ibuprofen) Alra Laboratories,
Tablets, 800 mg. Inc.
ANDA 072022............... Triamterene and American
Hydrochlorothiazide Therapeutics, Inc.
Tablets, 75 mg/50 mg.
ANDA 072129............... Maprotiline HCl Do.
Tablets USP, 25 mg.
ANDA 072130............... Maprotiline HCl Do.
Tablets USP, 50 mg.
ANDA 072131............... Maprotiline HCl Do.
Tablets USP, 75 mg.
ANDA 072190............... Metaproterenol Wockhardt EU
Sulfate Inhalation Operations (Swiss)
Solution, 5%. AG, c/o Morton Grove
Pharmaceuticals,
Inc.
ANDA 072196............... Milophene (clomiphene Milex Products, Inc.,
citrate) Tablets, 50 5915 Northwest
mg. Highway, Chicago, IL
60631.
ANDA 072255............... Microderm Johnson and Johnson
(chlorhexidine Medical, Inc., 2500
gluconate) Topical Arbrook Blvd.,
Solution, 4%. Arlington, TX 76014.
[[Page 1164]]
ANDA 072292............... Prevacare R Do.
(chlorhexidine
gluconate) Topical
Solution, 0.5%.
ANDA 072295............... Microderm Do.
(chlorhexidine
gluconate) Topical
Sponge, 4%.
ANDA 072307............... Fenoprofen Calcium American
Capsules USP, 200 mg. Therapeutics, Inc.
ANDA 072308............... Fenoprofen Calcium Do.
Capsules USP, 300 mg.
ANDA 072309............... Fenoprofen Calcium Do.
Tablets USP, 600 mg.
ANDA 072782............... Prazosin HCl Capsules Do.
USP, 1 mg.
ANDA 072783............... Prazosin HCl Capsules Do.
USP, 2 mg.
ANDA 072784............... Prazosin HCl Capsules Do.
USP, 5 mg.
ANDA 073416............... E-Z Scrub Becton Dickinson
(chlorhexidine Surgical System,
gluconate) Topical 9450 South State
Sponge, 4%. St., Sandy, UT
84070.
ANDA 073535............... Piroxicam Capsules, Mutual Pharmaceutical
10 mg. Co., Inc., 1100
Orthodox St.,
Philadelphia, PA
19124.
ANDA 074523............... Metromidol Laboratorios
(metronidazole) Applicaciones
Tablets, 250 mg and Farmaceuticas S.A.
500 mg. de CV, c/o Richard
Hamer Association,
Inc., P.O. Box
16598, Fort Worth,
TX 76162.
ANDA 074560............... Flurbiprofen Tablets Theragen, Inc., 10
USP, 100 mg. Lake Dr., East
Windsor, NJ 08520.
ANDA 074702............... Metaproterenol Wockhardt EU
Sulfate Syrup, 10 mg/ Operations (Swiss)
5 mL. AG, c/o Morton Grove
Pharmaceuticals,
Inc.
ANDA 074881............... Iopamidol Injection, Cook Imaging Corp.,
41%, 51%, 61%, and 927 South Curry
76%. Pike, P.O. Box 3068,
Bloomington, IN
47403.
ANDA 074988............... Aspirin, Caffeine, Jerome Stevens
and Orphenadrine Pharmaceuticals,
Citrate Tablets, 385 Inc.
mg/30 mg/25 mg and
770 mg/60 mg/50 mg.
ANDA 075181............... Prednisolone Sodium WE Pharmaceuticals,
Phosphate Oral Inc.
Solution, EQ 5 mg
base/5 mL.
ANDA 075260............... Tretinoin Topical Wockhardt EU
Solution, 0.05%. Operations (Swiss)
AG, c/o Morton Grove
Pharmaceuticals,
Inc.
ANDA 075414............... Nifedipine Extended- Martec USA, LLC, 1800
Release Tablets, 90 North Topping Ave.,
mg. Kansas City, MO
64120.
ANDA 075507............... Ipratropium Bromide Pharmascience, Inc.,
Inhalation Solution, 10 Orchard Pl.,
0.02%. Tenafly City, NJ
07670.
ANDA 075569............... Thallous Chloride TL Trace Life Sciences,
201 Injection USP, 1 Inc., 2101 Shady
millicurie (mCi)/mL. Oaks, Denton, TX
76205.
ANDA 075586............... Metaproterenol Wockhardt EU
Sulfate Inhalation Operations (Swiss)
Solution, 0.4% and AG, c/o Morton Grove
0.6%. Pharmaceuticals,
Inc.
ANDA 075619............... Minoxidil Extra Avacor Products, LLC,
Strength (for Men) 227 East 56th St.,
Topical Solution, 5%. 3rd Floor, New York,
NY 10022.
ANDA 075766............... Calcitriol Injection, Fresenius Medical
1 microgram (mcg)/mL Care North America,
and 2 mcg/mL. 95 Hayden Ave.,
Lexington, MA 02421.
ANDA 075941............... Strontium Chloride SR- Bio-Nucleonics, Inc.,
89 Injection, 1 mCi/ 1600 Market St.,
mL. Suite 13200,
Philadelphia, PA
19103.
ANDA 077072............... Ipratropium Bromide Landela
Inhalation Solution, Pharmaceutical, 776
0.02%. East Riverside Dr.,
Suite 150, Eagle, ID
83616.
ANDA 077218............... ThyroShield Arco Pharmaceuticals,
(potassium iodide) LLC, 7605 Maryland
Oral Solution USP, Ave., St. Louis, MO
65 mg/mL. 63105.
ANDA 077569............... Albuterol Sulfate Landela
Inhalation Solution, Pharmaceutical.
EQ 0.083% base.
ANDA 080024............... Sulfacel-15 Optopics Laboratories
(sulfacetamide Corp., P.O. Box 210,
sodium) Ophthalmic Fairton, NJ 08320.
Solution, 15%.
ANDA 080036............... Sosol (sulfisoxazole) MK Laboratories,
Tablets, 500 mg. Inc., 424 Grasmere
Ave., Fairfield, CT
06430.
ANDA 080366............... Soxazole Alra Laboratories,
(sulfisoxazole) Inc.
Tablets, 500 mg.
ANDA 080380............... Bamate (meprobamate) Do.
Tablets, 200 mg and
400 mg.
ANDA 080483............... Hi-cor C and M Pharmacal,
(hydrocortisone) Inc., 1519 East 8
Cream, 2.5%. Mile Rd., Hazel
Park, MI 48030.
ANDA 080492............... Reserpine Tablets, Marshall Pharmacal
0.1 mg and 0.25 mg. Corp., 89 Michael
St., South
Hackensack, NJ
07606.
ANDA 080518............... Dimenhydrinate Alra Laboratories,
Tablets, 50 mg. Inc.
ANDA 080519............... Diphenhydramine HCl Do.
Capsules, 25 mg and
50 mg.
ANDA 080525............... Reserpine Tablets, MK Laboratories, Inc.
0.1 mg and 0.25 mg.
ANDA 080592............... Diphenhydramine HCl Valeant
Capsules, 50 mg. Pharmaceuticals
International, One
Enterprise, Aliso
Viejo, CA 92656.
ANDA 080660............... Ocusulf Miza Pharmaceuticals
(sulfacetamide USA, Inc., c/o
sodium) Ophthalmic Optopics
Solution, 10% and Laboratories, 40
30%. Main St., P.O. Box
210, Fairton, NJ
08320.
ANDA 080714............... Diphenhydramine HCl Alra Laboratories,
Oral Solution, 12.5 Inc.
mg/5 mL.
ANDA 080715............... Dimenhydrinate Oral Do.
Solution, 12.5 mg/4
mL.
ANDA 080941............... Isoniazid Tablets, MK Laboratories, Inc.
100 mg.
ANDA 080970............... Methscopolamine Private Formulations,
Bromide Tablets, 2.5 Inc., 460 Plainfield
mg. Ave., Edison, NJ
08818.
ANDA 081145............... Aspirin and Jerome Stevens
Methocarbamol Pharmaceuticals,
Tablets, 325 mg/400 Inc.
mg.
ANDA 083001............... Triamcinolone Lederle Laboratories,
Acetonide Aerosol Division of American
Foam Emulsion. Cyanamid Co., Pearl
River, NY 10965-
1215.
ANDA 083087............... Diphenhydramine HCl MK Laboratories, Inc.
Capsules, 25 mg and
50 mg.
ANDA 083088............... Diphenhydramine HCl Do.
Elixir, 12.5 mg/5 mL.
ANDA 083264............... Pentobarbital Sodium Valeant
Capsules, 100 mg. Pharmaceuticals
International.
[[Page 1165]]
ANDA 083286............... Chlorpheniramine Marshall Pharmacal
Maleate Tablets. Corp.
ANDA 083315............... Procaine HCl Elkins Sinn
Injection, 1% and 2%. Pharmaceutical Co.,
c/o ESI Lederle, 2
Esterbrook Ln.,
Cherry Hill, NJ
08003.
ANDA 083320............... Acetazolamide Alra Laboratories,
Tablets, 250 mg. Inc.
ANDA 083389............... Epinephrine and Dell Laboratories,
Lidocaine HCl Inc., 668 Front St.,
Injection, 0.01 mg/ Teaneck, NJ 07666.
mL and 1%.
ANDA 083390............... Epinephrine and Do.
Lidocaine HCl
Injection, 0.01 mg/
mL and 2%.
ANDA 083457............... Vitamin A Palmitate MK Laboratories, Inc.
Capsules, EQ 25,000
units base and EQ
50,000 units base.
ANDA 083524............... Butabarbital Sodium Marshall Pharmacal
Tablets, 16.2 mg. Corp.
ANDA 083525............... Niacin Tablets, 500 MK Laboratories, Inc.
mg.
ANDA 083526............... Folic Acid Tablets, 1 Do.
mg.
ANDA 083658............... Promethazine HCl Private Formulations,
Tablets, 25 mg. Inc.
ANDA 083806............... Dexamethasone Phoenix Laboratories,
Tablets, 0.75 mg. Inc., 175 Lauman
Ln., East
Hicksville, NY
11801.
ANDA 083827............... Pramine (imipramine Alra Laboratories,
HCl) Tablets, 10 mg, Inc.
25 mg, and 50 mg.
ANDA 083858............... Butabarbital Sodium Marshall Pharmacal
Tablets, 32.4 mg. Corp.
ANDA 083863............... Sulfisoxazole Cream.. Holland Rantos Co.,
Inc., P.O. Box 385,
Piscataway, NJ
08854.
ANDA 084185............... Bethanechol Chloride Wendt Laboratories,
Tablets, 10 mg. Inc., 200 West
Beaver, P.O. Box
128, Belle Plaine,
MN 56011.
ANDA 084186............... Bethanechol Chloride Do.
Tablets, 25 mg.
ANDA 084188............... Myotonachol Glenwood, Inc., 83
(bethanechol North Summit St.,
chloride) Tablets, 5 P.O. Box 518,
mg, 10 mg, and 25 mg. Tenafly, NJ 07670.
ANDA 084246............... Cortisone Acetate Everylife, 2021 15th
Tablets, 25 mg. Ave., West Seattle,
WA 98119.
ANDA 084439............... Prednisolone Tablets, Do.
1 mg, 2.5 mg, and 5
mg.
ANDA 084440............... Prednisone Tablets, 1 Do.
mg, 2.5 mg, and 5 mg.
ANDA 084494............... Hydrochlorothiazide West-Ward
Tablets. Pharmaceutical Corp.
ANDA 084590............... Pentobarbital Sodium Anabolic, Inc., 1835
Capsules, 100 mg. East Cheyenne Rd.,
Colorado Springs, CO
80905.
ANDA 084631............... Quinidine Sulfate Sandoz, Inc., 4700
Tablets USP, 200 mg. Eon Dr., Wilson, NC
27893.
ANDA 084687............... Niacin Tablets, 500 Zzeon
mg. Pharmaceuticals,
Ltd., Jamboree at
Kevin, Irvine, CA
92705,
ANDA 084714............... Hydro-Reserp ABC Holding Corp.,
(hydrochlorothiazide P.O. Box 307, 70945
and reserpine) Van Dyke Ave.,
Tablets, 50 mg/0.125 Romeo, MI 48065.
mg.
ANDA 084729............... Lidocaton Pharmaton, Ltd., c/o
(epinephrine and Bass Ullmna and
lidocaine HCl) Lustigman, 747 3rd
Injection, 0.01 mg/ Ave., New York, NY
mL and 2%. 10017.
ANDA 084803............... Chlorpromazine HCl Lederle Laboratories,
Tablets, 10 mg. Division of American
Cyanamid Co., Pearl
River, NY 10965-
1215.
ANDA 084872............... Meclizine HCl CM Bundy Co., 2055
Tablets, 25 mg. Reading Rd.,
Cincinnati, OH
45205.
ANDA 084902............... Promethacon Polymedica
(promethazine HCl) Industries, Inc., 2
Suppository, 50 mg. Constitution Way,
Woburn, MA 01801.
ANDA 084931............... Methamphetamine HCl Rexar Pharmacal, 396
Tablets, 5 mg and 10 Rockaway Ave.,
mg. Valley Stream, NY
11581.
ANDA 084933............... Diethylstilbestrol West-Ward
Tablets, 1 mg. Pharmaceutical Corp.
ANDA 084977............... Halothane Inhalation, BH Chemicals, Inc.,
99.99%. 500 5th Ave., New
York, NY 10036.
ANDA 085009............... Lygen Alra Laboratories,
(chlordiazepoxide Inc.
HCl) Capsules, 10 mg.
ANDA 085039............... Folic Acid Tablets Wendt Laboratories,
USP, 1 mg. Inc.
ANDA 085040............... Isoniazid Tablets Do.
USP, 100 mg.
ANDA 085041............... Meclizine HCl Do.
Tablets, 25 mg.
ANDA 085042............... Methocarbamol Tablets Do.
USP, 500 mg.
ANDA 085044............... Reserpine Tablets Do.
USP, 0.25 mg.
ANDA 085075............... Aerolate III Fleming and Co.
(theophylline) Pharmaceuticals,
Extended-Release Inc., 1600 Fenton
Capsules, 65 mg. Park Dr., Fenton, MO
63026.
Aerolate JR
(theophylline)
Extended-Release
Capsules, 130 mg..
Aerolate SR
(theophylline)
Extended-Release
Capsules, 260 mg..
ANDA 085107............... Lygen Alra Laboratories,
(chlordiazepoxide Inc.
HCl) Capsules, 5 mg.
ANDA 085108............... Lygen Do.
(chlordiazepoxide
HCl) Capsules, 25 mg.
ANDA 085125............... Methyltestosterone Tablicaps, Inc., P.O.
Sublingual Tablets, Box 5555,
10 mg. Franklinville, NJ
08322.
ANDA 085217............... Acetaminophen and Everylife.
Codeine Phosphate
Tablets, 325 mg/30
mg.
ANDA 085235............... Chlordiazepoxide HCl Abbott Laboratories,
Capsules. Pharmaceutical
Products Division,
100 Abbott Park Rd.,
Abbott Park, IL
60064.
ANDA 085236............... Chlordiazepoxide HCl Do.
Capsules.
ANDA 085252............... Meclizine HCl ABC Holding Corp.
Tablets, 25 mg.
ANDA 085253............... Meclizine HCl Do.
Tablets, 12.5 mg.
ANDA 085282............... Hydrocortisone Mericon Industries,
Lotion, 0.5% and 1%. Inc., 8819 North
Pioneer Rd., Peoria,
IL 61615.
ANDA 085383............... Butabarbital Sodium Wockhardt EU
Elixir, 30 mg/5 mL. Operations (Swiss)
AG, c/o Morton Grove
Pharmaceuticals,
Inc.
[[Page 1166]]
ANDA 085411............... Phentermine HCl ABC Holding Corp.
Capsules, 30 mg.
ANDA 085511............... Cam-Metrazine Do.
(phendimetrazine
tartrate) Tablets,
35 mg.
ANDA 085512............... Phenazine-35 Do.
(phendimetrazine
tartrate) Tablets,
35 mg.
ANDA 085550............... Butabarbital Sodium CM Bundy Co.
Tablets, 30 mg.
ANDA 085569............... Chlorothiazide ABC Holding Corp.
Tablets, 250 mg.
ANDA 085587............... Meclizine Camall Co., Inc.,
Hydrochloride 60950 Van Dyke Ave.,
Chewable Tablets. P.O. Box 218,
Washington, MI
48094.
ANDA 085638............... Codeine, Aspirin, Scherer Laboratories,
APAP Formula No. 4 Inc., 2301 Ohio Dr.,
(codeine phosphate, Suite 234, Plano, TX
aspirin, and 75093.
acetaminophen)
Capsules, 60 mg/180
mg/150 mg.
ANDA 085639............... Codeine, Aspirin, Do.
APAP Formula No. 3
(codeine phosphate,
aspirin, and
acetaminophen)
Capsules, 30 mg/180
mg/150 mg.
ANDA 085640............... Codeine, Aspirin, Do.
APAP Formula No. 2
(codeine phosphate,
aspirin, and
acetaminophen)
Capsules, 15 mg/180
mg/150 mg.
ANDA 085672............... Hydrochlorothiazide ABC Holding Corp.
Tablets, 50 mg.
ANDA 085756............... Cam-Metrazine Camall Co., Inc.
(phendimetrazine
tartrate) Tablets,
35 mg.
ANDA 085766............... Atropine Sulfate and Private Formulations,
Diphenoxylate HCl Inc.
Tablets, 0.025 mg/
2.5 mg.
ANDA 085882............... Duvoid (bethanechol Chartwell RX
chloride) Tablets, Sciences, LLC, 77
50 mg. Brenner Dr.,
Congers, NY 10920.
ANDA 085888............... Brompheniramine Leiner Health
Maleate Tablets. Products, Inc.
ANDA 085891............... Meclizine HCl Anabolic, Inc.
Tablets, 25 mg.
ANDA 085895............... Secobarbital Sodium Everylife.
Capsules, 100 mg.
ANDA 086008............... Hydrocortisone and Bioglan Laboratories,
Urea Cream, 1%/10%. Ltd., 450 Hilltop
Rd., Riegelsville,
PA 18077.
ANDA 086077............... Nitrofurazone Ambix Laboratories,
Ointment, 0.2%. Division of Organics
Corp. of America.
ANDA 086079............... Hydrocortisone Do.
Ointment, 1%.
ANDA 086080............... Hydrocortisone Cream, Do.
1%.
ANDA 086141............... Tolbutamide Tablets, Alra Laboratories,
500 mg. Inc.
ANDA 086260............... Ona-Mast (phentermine MM Mast and Co.
HCl) Tablets, 8 mg.
ANDA 086262............... Duvoid (bethanechol Chartwell RX
chloride) Tablets, Sciences, LLC.
10 mg.
ANDA 086263............... Duvoid (bethanechol Do.
chloride) Tablets,
25 mg.
ANDA 086271............... Hydrocortisone Cream, Ambix Laboratories,
2.5%. Division of Organics
Corp. of America.
ANDA 086272............... Hydrocortisone Do.
Ointment, 2.5%.
ANDA 086498............... Amitriptyline HCl Alra Laboratories,
Tablets, 10 mg. Inc.
ANDA 086499............... Amitriptyline HCl Do.
Tablets, 50 mg.
ANDA 086500............... Amitriptyline HCl Do.
Tablets, 150 mg.
ANDA 086501............... Amitriptyline HCl Do.
Tablets, 100 mg.
ANDA 086502............... Amitriptyline HCl Do.
Tablets, 25 mg.
ANDA 086503............... Amitriptyline HCl Do.
Tablets, 75 mg.
ANDA 086511............... Ona-Mast (phentermine MM Mast and Co.
HCl) Capsules, 30 mg.
ANDA 086516............... Ona-Mast (phentermine Do.
HCl) Capsules, 30 mg.
ANDA 086550............... X-Trozine Shire Richwood, Inc.,
(phendimetrazine 7900 Tanners Gate
tartrate) Tablets, Dr., Suite 200,
35 mg. Florence, KY 41042.
ANDA 086551............... X-Trozine Do.
(phendimetrazine
tartrate) Tablets,
35 mg.
ANDA 086552............... X-Trozine Do.
(phendimetrazine
tartrate) Tablets,
35 mg.
ANDA 086553............... X-Trozine Do.
(phendimetrazine
tartrate) Tablets,
35 mg.
ANDA 086554............... X-Trozine Do.
(phendimetrazine
tartrate) Tablets,
35 mg.
ANDA 086735............... Phentermine HCl Camall Co., Inc.
Capsules, 15 mg.
ANDA 086748............... Theophylline Elixir, Wockhardt EU
80 mg/15 mL. Operations (Swiss)
AG, c/o Morton Grove
Pharmaceuticals,
Inc.
ANDA 086766............... Nitrofurazone Wendt Laboratories,
Ointment, 0.2%. Inc.
ANDA 087081............... Nitrofurazone Topical Do.
Solution, 0.2%.
ANDA 087226............... Phentermine HCl Camall Co., Inc.
Capsules, 30 mg.
ANDA 087371............... X-Trozine L.A. Shire Richwood, Inc.
(phendimetrazine
tartrate) Extended-
Release Capsules,
105 mg.
ANDA 087392............... Aminophylline Pharma Serve, Inc.,
Injection, 25 mg/mL. Subsidiary of
Torigian
Laboratories, 218-20
98th Ave., Queens
Village, NY 11429.
ANDA 087394............... X-Trozine Shire Richwood, Inc.
(phendimetrazine
tartrate) Capsules,
35 mg.
ANDA 087442............... Neosar Bedford Laboratories,
(cyclophosphamide) Division of Ben
for Injection, 100 Venue Laboratories,
mg/vial, 200 mg/ Inc., 300 Northfield
vial, 500 mg/vial, 1 Rd., Bedford, OH
g/vial, and 2 g/vial. 44146.
ANDA 087487............... Melfiat-105 Numark Laboratories,
(phendimetrazine Inc., 75 Mayfield
tartrate) Extended- Ave., Edison, NJ
Release Capsules, 08837.
105 mg.
ANDA 087636............... Tropicamide Miza Pharmaceuticals
Ophthalmic Solution, USA, Inc., c/o
0.5%. Optopics
Laboratories.
ANDA 087637............... Tropicamide Do.
Ophthalmic Solution,
1%.
ANDA 087681............... Paracaine Optopics Laboratories
(proparacaine HCl) Corp.
Ophthalmic Solution,
0.5%.
ANDA 087764............... Oby-Trim (phentermine Shire Richwood, Inc.
HCl) Capsules, 30 mg.
ANDA 087932............... Triamcinolone Ambix Laboratories,
Acetonide Cream, Division of Organics
0.025%. Corp. of America.
ANDA 088786............... Sodium Polystyrene Wockhardt EU
Sulfonate USP Operations (Swiss)
Powder, 453.6 g/ AG, c/o Morton Grove
bottle. Pharmaceuticals,
Inc.
[[Page 1167]]
ANDA 088897............... Promethazine VC Plain Do.
(phenylephrine HCl
and promethazine
HCl) Syrup, 5 mg/5
mL and 6.25 mg/5 mL.
ANDA 089141............... Aerolate Fleming and Co.
(theophylline) Oral Pharmaceuticals,
Solution, 150 mg/15 Inc.
mL.
ANDA 089417............... Methocarbamol Tablets American
USP, 500 mg. Therapeutics, Inc.
ANDA 089418............... Methocarbamol Tablets Do.
USP, 750 mg.
ANDA 089478............... Acetaminophen and Do.
Codeine Phosphate
Tablets USP, 300 mg/
15 mg.
ANDA 089479............... Acetaminophen and Do.
Codeine Phosphate
Tablets USP, 300 mg/
30 mg.
ANDA 089480............... Acetaminophen and Do.
Codeine Phosphate
Tablets USP, 300 mg/
60 mg.
ANDA 089514............... Trihexyphenidyl HCl Pharmaceutical
Elixir, 2 mg/5 mL. Ventures, Ltd., P.O.
Box D3700, Pomona,
NY 10970.
ANDA 089726............... Prednisone Oral Wockhardt EU
Solution, 5 mg/5 mL. Operations (Swiss)
AG, c/o Morton Grove
Pharmaceuticals,
Inc.
ANDA 204472............... Fludeoxyglucose F-18 MIPS Cyclotron and
Injection USP, 20- Radiochemistry
300 mCi/mL. Facility, 1201 Welch
Rd., Rm. PS049,
Stanford, CA 94305.
ANDA 204517............... Sodium Fluoride F-18 Do.
Injection, 10-200
mCi/mL.
ANDA 204535............... Ammonia N-13 Do.
Injection USP, 3.75-
37.5 mCi/mL.
------------------------------------------------------------------------
Therefore, under Sec. Sec. 314.150(b)(1) and 314.200 (21 CFR
314.150(b)(1) and 314.200), notice is given to the holders of the
approved ANDAs listed in the table and to all other interested persons
that the Director of CDER proposes to issue an order under section
505(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 355(e)) withdrawing approval of the ANDAs and all amendments and
supplements to them on the grounds that the ANDA holders have failed to
submit reports required under Sec. Sec. 314.81 and 314.98.
In accordance with section 505 of the FD&C Act and part 314 (21 CFR
part 314), the ANDA holders are hereby provided an opportunity for a
hearing to show why the applications listed previously should not be
withdrawn and an opportunity to raise, for an administrative
determination, all issues relating to the legal status of the drug
products covered by these ANDAs.
An ANDA holder who decides to seek a hearing must file the
following: (1) A written notice of participation and request for a
hearing (see DATES and ADDRESSES) and (2) the data, information, and
analyses relied on to demonstrate that there is a genuine and
substantial issue of fact that requires a hearing (see DATES and
ADDRESSES). Any other interested person may also submit comments on
this notice. The procedures and requirements governing this notice of
opportunity for a hearing, the notice of participation and request for
a hearing; the information and analyses to justify a hearing, other
comments, and a grant or denial of a hearing are contained in Sec.
314.200 and in 21 CFR part 12.
The failure of an ANDA holder to file a timely written notice of
participation and request for a hearing, as required by Sec. 314.200,
constitutes an election by that ANDA holder not to avail itself of the
opportunity for a hearing concerning CDER's proposal to withdraw
approval of the ANDAs and constitutes a waiver of any contentions
concerning the legal status of the drug products. FDA will then
withdraw approval of the ANDAs, and the drug products may not
thereafter be lawfully introduced or delivered for introduction into
interstate commerce. Any new drug product introduced or delivered for
introduction into interstate commerce without an approved ANDA is
subject to regulatory action at any time.
A request for a hearing may not rest upon mere allegations or
denials but must present specific facts showing that there is a genuine
and substantial issue of fact that requires a hearing. If a request for
a hearing is not complete or is not supported, the Commissioner of Food
and Drugs will enter summary judgment against the person who requests
the hearing, making findings and conclusions, and denying a hearing.
All submissions under this notice of opportunity for a hearing must
be filed in four copies. Except for data and information prohibited
from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, the
submissions may be seen at the Dockets Management Staff (see ADDRESSES)
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at https://www.regulations.gov.
This notice is issued under section 505(e) of the FD&C Act and
under authority delegated to the Director of CDER by the Commissioner
of Food and Drugs.
Dated: January 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00120 Filed 1-8-20; 8:45 am]
BILLING CODE 4164-01-P
