Fresenius USA, Inc., et al.; Withdrawal of Approval of 216 Abbreviated New Drug Applications, 58675-58681 [2021-23075]
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Federal Register / Vol. 86, No. 202 / Friday, October 22, 2021 / Notices
Application No.
Drug name
Active ingredient(s)
Strength(s)
Dosage form/route
NDA 022510 ...
ABSTRAL ....................
Fentanyl Citrate ...........
Tablet; Sublingual .......
Sentynl Therapeutics,
Inc.
NDA 050011 ...
PATHOCIL ..................
Dicloxacillin Sodium ....
Capsule; Oral ..............
Wyeth-Ayerst Labs.
NDA 204308 ...
EPANED KIT ...............
Enalapril Maleate ........
EQ 0.1 mg base; EQ
0.2 mg base; EQ 0.3
mg base; EQ 0.4 mg
base; EQ 0.6 mg
base; EQ 0.8 mg
base.
EQ 250 mg base; EQ
500 mg base.
1 mg/mL ......................
For Solution; Oral ........
NDA 207233 ...
VIVLODEX ..................
Meloxicam ...................
5 mg; 10 mg ................
Capsule; Oral ..............
Silvergate Pharms.,
Inc.
Zyla.
FDA has reviewed its records and,
under § 314.161, has determined that
the drug products listed were not
withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the
Agency will continue to list the drug
products in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. The Discontinued Drug Product
List identifies, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness.
Approved ANDAs that refer to the
NDAs listed are unaffected by the
discontinued marketing of the products
subject to those NDAs. Additional
ANDAs that refer to these products may
also be approved by the Agency if they
comply with relevant legal and
regulatory requirements. If FDA
determines that labeling for these drug
products should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: October 19, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–23084 Filed 10–21–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–1037]
Fresenius USA, Inc., et al.; Withdrawal
of Approval of 216 Abbreviated New
Drug Applications
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
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58675
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 216
abbreviated new drug applications
(ANDAs) from multiple holders of those
ANDAs. The basis for the withdrawal is
that these ANDA holders have
SUMMARY:
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repeatedly failed to submit required
annual reports for those ANDAs.
DATES: Approval is withdrawn as of
November 22, 2021.
FOR FURTHER INFORMATION CONTACT:
James Hanratty, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1671,
Silver Spring, MD 20993–0002, 240–
402–4718, James.Hanratty@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
holders of an approved application to
market a new drug for human use are
required to submit annual reports to
FDA concerning their approved
application in accordance with
§§ 314.81 and 314.98 (21 CFR 314.81
and 314.98). In the Federal Register of
January 9, 2020 (85 FR 1160), FDA
published a notice offering an
opportunity for a hearing (NOOH) on a
proposal to withdraw approval of 249
ANDAs because the holders of those
ANDAs had repeatedly failed to submit
the required annual reports for those
ANDAs (‘‘Fresenius USA, Inc., et al.;
Proposal To Withdraw Approval of 249
Abbreviated New Drug Applications;
Opportunity for a Hearing’’).1 The
holder of ANDA 085882, ANDA 086262,
and ANDA 0866263 responded to the
NOOH and requested a hearing. The
remaining holders of those ANDAs did
not respond to the NOOH. Failure to file
a written notice of participation and
request for hearing as required by
§ 314.200 constitutes an election by
those holders of the ANDAs not to make
use of the opportunity for a hearing
concerning the proposal to withdraw
approval of their ANDAs and a waiver
of any contentions concerning the legal
status of the drug products. Therefore,
FDA is withdrawing approval of the 216
applications listed in table 1.
I. Annual Reports Submitted
In response to the NOOH, one firm
requested a hearing and had previously
1 85 FR 1160, published on January 9, 2020,
incorrectly listed 249 as the number of the ANDAs
FDA proposed to withdrawal. 85 FR 1160 listed 248
ANDAs in the table included in the notice.
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Fmt 4703
Sfmt 4703
Applicant
submitted an annual report for each of
its three ANDAs. Therefore, FDA
rescinds its proposal to withdraw
approval of the following three ANDAs:
Chartwell RX Sciences, LLC, 77 Brenner
Dr., Congers, NY 10920:
• ANDA 085882, DUVOID (bethanechol
chloride) Tablets, 50 milligrams (mg)
• ANDA 086262, DUVOID (bethanechol
chloride) Tablets, 10 mg
• ANDA 086263, DUVOID (bethanechol
chloride) Tablets, 25 mg
Another three firms notified the
Agency that they had submitted an
annual report for each of its ANDAs
listed in the NOOH. Therefore, FDA
rescinds its proposal to withdraw
approval of the following eight ANDAs:
Jerome Stevens Pharmaceuticals Inc.,
60 DaVinci Dr., Bohemia, NY 11716:
• ANDA 062869, CEPHALEXIN
Capsules USP, EQ 500 mg base
• ANDA 062870, CEPHALEXIN
Capsules USP, EQ 250 mg base
• ANDA 074988, ASPIRIN, CAFFEINE,
AND ORPHENADRINE CITRATE
Tablets, 385 mg/30 mg/25 mg, and
770 mg/60 mg/50 mg
• ANDA 081145, ASPIRIN AND
METHOCARBAMOL Tablets, 325 mg/
400 mg
MIPS Cyclotron and Radiochemistry
Facility, 1201 Welch Rd., Rm. PS049,
Stanford, CA 94305:
• ANDA 204472, FLUDEOXYGLUCOSE
F–18 Injection USP, 20–300
millicuries (mCi)/milliliters (mL)
• ANDA 204517, SODIUM FLUORIDE
F–18 Injection, 10–200 mCi/mL
• ANDA 204535, AMMONIA N–13
Injection USP, 3.75–37.5 mCi/mL
Milex Products, Inc., 5915 Northwest
Hwy., Chicago, IL 60631:
• ANDA 072196, MILOPHENE
(clomiphene citrate) Tablets, 50 mg
II. Previously Consolidated Application
Sandoz, Inc., 4700 Eon Dr., Wilson,
NC 27893, notified the Agency that
ANDA 084631, QUINIDINE SULFATE
Tablets USP, 200 mg, had previously
been consolidated with ANDA 088072.
Therefore, FDA rescinds its proposal to
withdraw approval of this ANDA.
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Federal Register / Vol. 86, No. 202 / Friday, October 22, 2021 / Notices
III. Previously Transferred Application
Pfizer Laboratories, Division of Pfizer,
Inc., 235 East 42nd St., New York, NY
10017, notified the Agency that ANDA
060074, PENICILLIN G POTASSIUM for
Injection, 20,000,000 units/vial, had
previously been transferred to Cultor
Food Science, Inc. Therefore, FDA
rescinds its proposal to withdraw
approval of this ANDA.
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IV. Requests To Withdraw Approval
In response to the NOOH, 13 firms
notified the Agency that they no longer
market 15 of the ANDAs listed in the
NOOH and had previously submitted
written requests for withdrawal for the
following ANDAs:
1. Parkedale Pharmaceuticals, Inc.,
501 5th St., Bristol, TN 37620, notified
the Agency that they no longer market
the product for ANDA 060521,
HUMATIN (paromomycin sulfate)
Capsules USP, Equivalent to (EQ) 250
mg base. On May 12, 2021 (86 FR
26058), the Agency withdrew approval
of this ANDA at the written request of
the applicant.
2. Roerig Division of Pfizer Inc., 235
East 42nd St., New York, NY 10017,
notified the Agency that they no longer
market the product for ANDA 060709,
OLEANDOMYCIN Injection. On July 21,
2020 (85 FR 44096), the Agency
withdrew approval of this ANDA under
the written request of the applicant.
3. Pharmacia and Upjohn Co., 7171
Portage Rd., Kalamazoo, MI 49001,
notified the Agency that they no longer
market the product for ANDA 061034,
LINCOMYCIN HYDROCHLORIDE (HCl)
Powder. On May 12, 2021, the Agency
withdrew approval of this ANDA under
the written request of the applicant.
4. Lederle Laboratories, Division of
American Cyanamid Co., 401 North
Middletown Rd., Pearl River, NY 10965,
notified the Agency that they no longer
market the product for ANDA 061064,
NYSTATIN Ointment. On May 12, 2021,
the Agency withdrew approval of this
ANDA under the written request of the
applicant.
5. Pfizer Laboratories, Division of
Pfizer Inc., 235 East 42nd St., New York,
NY 10017, notified the Agency that they
no longer market the product for ANDA
061087, BENZOCAINE,
OXYTETRACYCLINE HCl, and
POLYMYXIN B SULFATE OTIC
Solution. On July 21, 2020, the Agency
withdrew approval of this ANDA under
the written request of the applicant.
6. Warner-Lambert Co., 201 Tabor Rd.,
Morris Plains, NJ 07950, notified the
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17:47 Oct 21, 2021
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Agency that they no longer market the
product for ANDA 061652,
OXYTETRACYCLINE Capsules. On May
12, 2021, the Agency withdrew approval
of this ANDA under the written request
of the applicant.
7. AH Robins Co., 1211 Sherwood
Ave., Richmond, VA 23220, notified the
Agency that they no longer market the
product for ANDA 061701,
TETRACYCLINE Syrup, 125 mg/5 mL.
On May 12, 2021, the Agency withdrew
approval of this ANDA under the
written request of the applicant.
8. Warner Chilcott, Division of
Warner Lambert-Pfizer, Inc., 235 East
42nd St., New York, NY 10017, notified
the Agency that they no longer market
the products for ANDA 061725,
TETRACYCLINE HCl Capsules, 250 mg
and 500 mg, and ANDA 062175,
TETRACYCLINE HCl Capsules, 250 mg.
On July 21, 2020, the Agency withdrew
approval of these ANDAs under the
written request of the applicant.
9. Lederle Laboratories, Division of
American Cyanamid Co., 1 Cyanamid
Plaza, Wayne, NJ 07470, notified the
Agency that they no longer market the
products for ANDA 061943,
CHLORAMPHENICOL Ophthalmic
Solution, 0.5 percent; ANDA 062215,
OXYTETRACYCLINE HCl Capsules. On
July 21, 2020, the Agency withdrew
approval of these ANDAs under the
written request of the applicant.
10. Warner-Lambert Co. notified the
Agency that they no longer market the
product for ANDA 062032, EYPAR
(erythromycin stearate) Tablets, EQ 250
mg base and EQ 500 mg base. On May
12, 2021, the Agency withdrew approval
of this ANDA under the written request
of the applicant.
11. Becton Dickinson and Co.,
Surgical System, 9450 South State St.,
Sandy, UT 84070, notified the Agency
that they no longer market the product
for ANDA 073416, E–Z SCRUB
(chlorhexidine gluconate) Topical
Sponge, 4 percent. On January 8, 2020
(85 FR 909), the Agency withdrew
approval of this ANDA under the
written request of the applicant.
12. Lederle Laboratories, Division of
American Cyanamid Co., Pearl River,
NY 10965–1215, notified the Agency
that they no longer market the products
for ANDA 083001, TRIAMCINOLONE
ACETONIDE Aerosol Foam Emulsion.
On May 12, 2021, the Agency withdrew
approval of this ANDA under the
written request of the applicant.
13. Lederle Laboratories, Division of
American Cyanamid Co., Pearl River,
NY 10965–1215, notified the Agency
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Fmt 4703
Sfmt 4703
that they no longer market the product
for ANDA 084803, CHLORPROMAZINE
HCl Tablets, 10 mg. On May 12, 2021,
the Agency withdrew approval of this
ANDA under the written request of the
applicant.
V. Previously Withdrawn Applications
In the Federal Register of September
25, 2020 (85 FR 60474), FDA published
a separate notice offering an opportunity
for a hearing (NOOH) on a proposal to
withdraw approval of ANDAs because
the holders of those ANDAs had
repeatedly failed to submit the required
annual reports and have failed to satisfy
the requirement to have an approved
risk evaluation and mitigation strategy
for the following ANDAs:
1. Everylife, 2021 15th Avenue West,
Seattle, WA 98119: ANDA 085217,
ACETAMINOPHEN and CODEINE
PHOSPHATE Tablet, 325 mg/30 mg.
2. Scherer Laboratories, Inc., 2301
Ohio Dr., Suite 234, Plano, TX 75093:
ANDA 085638, ACETAMINOPHEN,
ASPIRIN, and CODEINE, 150 mg/180
mg/60 mg; ANDA 085639,
ACETAMINOPHEN, ASPIRIN, and
CODEINE PHOSPHATE Capsule, 150
mg/180 mg/30 mg; ANDA 085640,
ACETAMINOPHEN, ASPIRIN, and
CODEINE PHOSPHATE Capsule, 150
mg/180 mg/15 mg.
The holders of the applications did
not respond to the Federal Register
NOOH of September 25, 2020. Failure to
submit a written notice of participation
and request for hearing as required by
§ 314.200 constitutes an election by
those holders not to make use of the
opportunity for a hearing concerning the
proposal to withdraw approval of their
ANDAs and a waiver of any contentions
concerning the legal status of the drug
products. On April 9, 2021 (86 FR
18542), the Agency withdrew approval
of these ANDAs.
VI. No Response to NOOH Received
The holders of the other 216
applications did not respond to the
NOOH. Failure to submit a written
notice of participation and request for
hearing as required by § 314.200
constitutes an election by those holders
not to make use of the opportunity for
a hearing concerning the proposal to
withdraw approval of their ANDAs and
a waiver of any contentions concerning
the legal status of the drug products.
Therefore, the Director, Center for Drug
Evaluation and Research, is
withdrawing approval of the 216
applications listed in table 1.
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Federal Register / Vol. 86, No. 202 / Friday, October 22, 2021 / Notices
58677
TABLE 1—APPROVED ANDAS FOR WHICH REQUIRED REPORTS HAVE NOT BEEN SUBMITTED
Application No.
Drug
ANDA 020374 .........
ANDA 040168 .........
Inpersol-LC/LM with Dextrose 1.5% (calcium chloride, dextrose, magnesium chloride, sodium chloride, sodium lactate) Intraperitoneal Solution, 18.4 mg/100 mL; 1.5 grams
(g)/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/
100 mL.
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 060131 .........
Tetracycline HCl Capsules ....................................................
ANDA 060461 .........
Neomycin Sulfate Ointment; Neomycin Sulfate and Hydrocortisone Acetate Ointment.
Penicillin G Potassium Powder .............................................
ANDA 040057 .........
ANDA 060602 .........
ANDA 060627 .........
ANDA 060769 .........
Tribiotic (polymyxin B sulfate, bacitracin, and neomycin sulfate) Ointment, 5000 units/400 units/5 mg.
Pyocidin-HC (neomycin sulfate, polymyxin B sulfate, and
hydrocortisone) Otic Solution.
Tetracycline Syrup .................................................................
ANDA 060773 .........
ANDA 060870 .........
Tetracycline Syrup .................................................................
Oxytetracycline Injection ........................................................
ANDA 061154 .........
ANDA 061209 .........
ANDA 061228 .........
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 061674 .........
ANDA 061697 .........
Penicillin V Potassium Tablets ..............................................
Griseofulvin Capsules ............................................................
ANDA 061699 .........
ANDA 061833 .........
Bacitracin Powder for Rx Compounding, 5,000,000 units/
bottle.
Oxytetracycline HCl Capsules, 250 mg ................................
ANDA 061847 .........
Bleomycin Sulfate Injection ...................................................
ANDA 060724 .........
ANDA 061521 .........
ANDA 061528 .........
ANDA 061529 .........
ANDA 061532 .........
ANDA 061601 .........
ANDA 061602 .........
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Applicant
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Fresenius USA, Inc., 2637 Shadelands Dr., Walnut Creek,
CA 94598.
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.
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.
John D. Copanos and Co., Inc., 6110 Robinwood Rd., Baltimore, MD 21225.
Ambix Laboratories, Division of Organics Corp. of America.
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.
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.
Leiner Health Products, Inc.
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.
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.
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Federal Register / Vol. 86, No. 202 / Friday, October 22, 2021 / Notices
TABLE 1—APPROVED ANDAS FOR WHICH REQUIRED REPORTS HAVE NOT BEEN SUBMITTED—Continued
Application No.
Drug
Applicant
ANDA 061857 .........
Penicillamine Powder ............................................................
ANDA 061903 .........
ANDA 062085 .........
ANDA 062205 .........
ANDA 062340 .........
Bacitracin Zinc and Polymyxin B Sulfate Ointment ..............
Tetracycline HCl Capsules, 250 mg ......................................
Cefaclor Capsules USP, EQ 250 mg base and EQ 500 mg
base.
Gentamicin Sulfate Injection ..................................................
ANDA 062467 .........
E-Solve 2 (erythromycin) Lotion, 2% ....................................
ANDA 062758 .........
ANDA 062944 .........
Eryzole (erythromycin ethylsuccinate and sulfisoxazole acetyl) Granules, EQ 200 mg base/5 mL; EQ 600 mg base/5
mL.
Clindamycin Phosphate Topical Solution USP, EQ 1% base
Chemiewerk Homberg, c/o Wallace Laboratories, Cranbury,
NJ 08512.
Ambix Laboratories, Division of Organics Corp. of America.
MM Mast and Co., 4152 Ruple Rd., Cleveland, OH 44121.
Ceph International Corp. c/o Mova Pharmaceutical Corp.,
State Rd. #1, Jose Garrido St., Cagus, PR 00725.
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.
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 072255 .........
Microderm (chlorhexidine gluconate) Topical Solution, 4% ..
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 ......................................
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 075181 .........
Prednisolone Sodium Phosphate Oral Solution, EQ 5 mg
base/5 mL.
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ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
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
072295
072307
072308
072309
072782
072783
072784
073535
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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.
Johnson and Johnson Medical, Inc., 2500 Arbrook Blvd.,
Arlington, TX 76014.
Do.
Do.
American Therapeutics, Inc.
Do.
Do.
Do.
Do.
Do.
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.
WE Pharmaceuticals, Inc.
E:\FR\FM\22OCN1.SGM
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Federal Register / Vol. 86, No. 202 / Friday, October 22, 2021 / Notices
58679
TABLE 1—APPROVED ANDAS FOR WHICH REQUIRED REPORTS HAVE NOT BEEN SUBMITTED—Continued
Application No.
Drug
Applicant
ANDA 075260 .........
Tretinoin Topical Solution, 0.05% .........................................
ANDA 075414 .........
Nifedipine Extended-Release Tablets, 90 mg .......................
ANDA 075507 .........
Ipratropium Bromide Inhalation Solution, 0.02% ...................
ANDA 075569 .........
Thallous Chloride TL 201 Injection USP, 1 mCi/mL .............
ANDA 075586 .........
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 .........
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.
MK Laboratories, Inc.
Do.
Valeant Pharmaceuticals International.
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 077569 .........
ANDA 080024 .........
080518
080519
080525
080592
ANDA
ANDA
ANDA
ANDA
080714
080715
080941
080970
.........
.........
.........
.........
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
ANDA
ANDA
ANDA
ANDA
083087
083088
083264
083286
083315
.........
.........
.........
.........
.........
Diphenhydramine HCl Capsules, 25 mg and 50 mg ............
Diphenhydramine HCl Elixir, 12.5 mg/5 mL ..........................
Pentobarbital Sodium Capsules, 100 mg ..............................
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 ........................................
ANDA 083390 .........
ANDA 083457 .........
ANDA
ANDA
ANDA
ANDA
ANDA
083524
083525
083526
083658
083806
.........
.........
.........
.........
.........
lotter on DSK11XQN23PROD with NOTICES1
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.
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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.
E:\FR\FM\22OCN1.SGM
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Federal Register / Vol. 86, No. 202 / Friday, October 22, 2021 / Notices
TABLE 1—APPROVED ANDAS FOR WHICH REQUIRED REPORTS HAVE NOT BEEN SUBMITTED—Continued
Application No.
Drug
Applicant
.........
.........
.........
.........
.........
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 084687 .........
Niacin Tablets, 500 mg .........................................................
ANDA 084714 .........
ANDA 084872 .........
ANDA 084902 .........
Hydro-Reserp (hydrochlorothiazide and reserpine) Tablets,
50 mg/0.125 mg.
Lidocaton (epinephrine and lidocaine HCl) Injection, 0.01
mg/mL and 2%.
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
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 .....................
Chlordiazepoxide HCl Capsules ............................................
Everylife, 2021 15th Ave., West Seattle, WA 98119.
Do.
Do.
West-Ward Pharmaceutical Corp.
Anabolic, Inc., 1835 East Cheyenne Rd., Colorado Springs,
CO 80905.
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.
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.
ANDA
ANDA
ANDA
ANDA
085236
085252
085253
085282
.........
.........
.........
.........
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
ANDA
.........
.........
.........
.........
.........
.........
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 HCl Chewable Tablets ..........................................
ANDA 085672 .........
ANDA 085756 .........
ANDA 085766 .........
ANDA
ANDA
ANDA
ANDA
ANDA
084246
084439
084440
084494
084590
lotter on DSK11XQN23PROD with NOTICES1
ANDA 084729 .........
085411
085511
085512
085550
085569
085587
ANDA
ANDA
ANDA
ANDA
085888
085891
085895
086008
.........
.........
.........
.........
Hydrochlorothiazide Tablets, 50 mg ......................................
Cam-Metrazine (phendimetrazine tartrate) Tablets, 35 mg ..
Atropine Sulfate and Diphenoxylate HCl Tablets, 0.025 mg/
2.5 mg.
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
086077
086079
086080
086141
086260
086271
086272
086498
086499
086500
086501
086502
086503
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
Nitrofurazone Ointment, 0.2% ...............................................
Hydrocortisone Ointment, 1% ...............................................
Hydrocortisone Cream, 1% ...................................................
Tolbutamide Tablets, 500 mg ................................................
Ona-Mast (phentermine HCl) Tablets, 8 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 ...........................................
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Alra Laboratories, Inc.
Do.
Tablicaps, Inc., P.O. Box 5555, Franklinville, NJ 08322.
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.
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.
ABC Holding Corp.
Camall Co., Inc.
Private Formulations, Inc.
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.
Ambix Laboratories, Division of Organics Corp. of America.
Do.
Alra Laboratories, Inc.
Do.
Do.
Do.
Do.
Do.
E:\FR\FM\22OCN1.SGM
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Federal Register / Vol. 86, No. 202 / Friday, October 22, 2021 / Notices
58681
TABLE 1—APPROVED ANDAS FOR WHICH REQUIRED REPORTS HAVE NOT BEEN SUBMITTED—Continued
Application No.
Drug
ANDA 086511 .........
ANDA 086516 .........
ANDA 086550 .........
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 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
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 087487 .........
ANDA
ANDA
ANDA
ANDA
087637
087681
087764
087932
088786
089141
089417
089418
089478
.........
.........
.........
.........
ANDA 089479 .........
ANDA 089480 .........
FDA finds that the holders of the
ANDAs listed in table 1 have repeatedly
failed to submit reports required by
§§ 314.81 and 314.98. In addition, under
§ 314.200, FDA finds that the holders of
the ANDAs have waived any
contentions concerning the legal status
of the drug products. Therefore, under
these findings, approval of the ANDAs
listed in table 1 and all amendments
and supplements thereto, is hereby
withdrawn, effective October 22, 2021.
lotter on DSK11XQN23PROD with NOTICES1
Applicant
Dated: October 19, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–23075 Filed 10–21–21; 8:45 am]
BILLING CODE 4164–01–P
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17:47 Oct 21, 2021
Jkt 256001
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.
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent
Commercialization License: CD28H
Domain-Containing Chimeric Antigen
Receptors and Methods of Use
National Institutes of Health,
Health and Human Services (HHS).
AGENCY:
ACTION:
Notice.
The National Institute of
Allergy and Infectious Diseases, an
institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an exclusive patent license to
Ankarys Therapeutics Inc., located at
SUMMARY:
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
110 Cumberland Street, Suite 520, M5R
3V5, Toronto, Ontario, Canada, to
practice the inventions embodied in the
patent applications listed in the
Supplementary Information section of
this notice.
DATES: Only written comments and/or
applications for a license which are
received by the Technology Transfer
and Intellectual Property Office,
National Institute of Allergy and
Infectious Diseases on or before
November 8, 2021 will be considered.
ADDRESSES: Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
exclusive patent license should be
directed to: Dawn Taylor-Mulneix,
Technology Transfer and Patent
Specialist, Technology Transfer and
E:\FR\FM\22OCN1.SGM
22OCN1
]]>Agencies
[Federal Register Volume 86, Number 202 (Friday, October 22, 2021)]
[Notices]
[Pages 58675-58681]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23075]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-1037]
Fresenius USA, Inc., et al.; Withdrawal of Approval of 216
Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 216 abbreviated new drug applications (ANDAs)
from multiple holders of those ANDAs. The basis for the withdrawal is
that these ANDA holders have repeatedly failed to submit required
annual reports for those ANDAs.
DATES: Approval is withdrawn as of November 22, 2021.
FOR FURTHER INFORMATION CONTACT: James Hanratty, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-
402-4718, [email protected].
SUPPLEMENTARY INFORMATION: The holders of an approved application to
market a new drug for human use are required to submit annual reports
to FDA concerning their approved application in accordance with
Sec. Sec. 314.81 and 314.98 (21 CFR 314.81 and 314.98). In the Federal
Register of January 9, 2020 (85 FR 1160), FDA published a notice
offering an opportunity for a hearing (NOOH) on a proposal to withdraw
approval of 249 ANDAs because the holders of those ANDAs had repeatedly
failed to submit the required annual reports for those ANDAs
(``Fresenius USA, Inc., et al.; Proposal To Withdraw Approval of 249
Abbreviated New Drug Applications; Opportunity for a Hearing'').\1\ The
holder of ANDA 085882, ANDA 086262, and ANDA 0866263 responded to the
NOOH and requested a hearing. The remaining holders of those ANDAs did
not respond to the NOOH. Failure to file a written notice of
participation and request for hearing as required by Sec. 314.200
constitutes an election by those holders of the ANDAs not to make use
of the opportunity for a hearing concerning the proposal to withdraw
approval of their ANDAs and a waiver of any contentions concerning the
legal status of the drug products. Therefore, FDA is withdrawing
approval of the 216 applications listed in table 1.
---------------------------------------------------------------------------
\1\ 85 FR 1160, published on January 9, 2020, incorrectly listed
249 as the number of the ANDAs FDA proposed to withdrawal. 85 FR
1160 listed 248 ANDAs in the table included in the notice.
---------------------------------------------------------------------------
I. Annual Reports Submitted
In response to the NOOH, one firm requested a hearing and had
previously submitted an annual report for each of its three ANDAs.
Therefore, FDA rescinds its proposal to withdraw approval of the
following three ANDAs:
Chartwell RX Sciences, LLC, 77 Brenner Dr., Congers, NY 10920:
ANDA 085882, DUVOID (bethanechol chloride) Tablets, 50
milligrams (mg)
ANDA 086262, DUVOID (bethanechol chloride) Tablets, 10 mg
ANDA 086263, DUVOID (bethanechol chloride) Tablets, 25 mg
Another three firms notified the Agency that they had submitted an
annual report for each of its ANDAs listed in the NOOH. Therefore, FDA
rescinds its proposal to withdraw approval of the following eight
ANDAs:
Jerome Stevens Pharmaceuticals Inc., 60 DaVinci Dr., Bohemia, NY
11716:
ANDA 062869, CEPHALEXIN Capsules USP, EQ 500 mg base
ANDA 062870, CEPHALEXIN Capsules USP, EQ 250 mg base
ANDA 074988, ASPIRIN, CAFFEINE, AND ORPHENADRINE CITRATE
Tablets, 385 mg/30 mg/25 mg, and 770 mg/60 mg/50 mg
ANDA 081145, ASPIRIN AND METHOCARBAMOL Tablets, 325 mg/400 mg
MIPS Cyclotron and Radiochemistry Facility, 1201 Welch Rd., Rm.
PS049, Stanford, CA 94305:
ANDA 204472, FLUDEOXYGLUCOSE F-18 Injection USP, 20-300
millicuries (mCi)/milliliters (mL)
ANDA 204517, SODIUM FLUORIDE F-18 Injection, 10-200 mCi/mL
ANDA 204535, AMMONIA N-13 Injection USP, 3.75-37.5 mCi/mL
Milex Products, Inc., 5915 Northwest Hwy., Chicago, IL 60631:
ANDA 072196, MILOPHENE (clomiphene citrate) Tablets, 50 mg
II. Previously Consolidated Application
Sandoz, Inc., 4700 Eon Dr., Wilson, NC 27893, notified the Agency
that ANDA 084631, QUINIDINE SULFATE Tablets USP, 200 mg, had previously
been consolidated with ANDA 088072. Therefore, FDA rescinds its
proposal to withdraw approval of this ANDA.
[[Page 58676]]
III. Previously Transferred Application
Pfizer Laboratories, Division of Pfizer, Inc., 235 East 42nd St.,
New York, NY 10017, notified the Agency that ANDA 060074, PENICILLIN G
POTASSIUM for Injection, 20,000,000 units/vial, had previously been
transferred to Cultor Food Science, Inc. Therefore, FDA rescinds its
proposal to withdraw approval of this ANDA.
IV. Requests To Withdraw Approval
In response to the NOOH, 13 firms notified the Agency that they no
longer market 15 of the ANDAs listed in the NOOH and had previously
submitted written requests for withdrawal for the following ANDAs:
1. Parkedale Pharmaceuticals, Inc., 501 5th St., Bristol, TN 37620,
notified the Agency that they no longer market the product for ANDA
060521, HUMATIN (paromomycin sulfate) Capsules USP, Equivalent to (EQ)
250 mg base. On May 12, 2021 (86 FR 26058), the Agency withdrew
approval of this ANDA at the written request of the applicant.
2. Roerig Division of Pfizer Inc., 235 East 42nd St., New York, NY
10017, notified the Agency that they no longer market the product for
ANDA 060709, OLEANDOMYCIN Injection. On July 21, 2020 (85 FR 44096),
the Agency withdrew approval of this ANDA under the written request of
the applicant.
3. Pharmacia and Upjohn Co., 7171 Portage Rd., Kalamazoo, MI 49001,
notified the Agency that they no longer market the product for ANDA
061034, LINCOMYCIN HYDROCHLORIDE (HCl) Powder. On May 12, 2021, the
Agency withdrew approval of this ANDA under the written request of the
applicant.
4. Lederle Laboratories, Division of American Cyanamid Co., 401
North Middletown Rd., Pearl River, NY 10965, notified the Agency that
they no longer market the product for ANDA 061064, NYSTATIN Ointment.
On May 12, 2021, the Agency withdrew approval of this ANDA under the
written request of the applicant.
5. Pfizer Laboratories, Division of Pfizer Inc., 235 East 42nd St.,
New York, NY 10017, notified the Agency that they no longer market the
product for ANDA 061087, BENZOCAINE, OXYTETRACYCLINE HCl, and POLYMYXIN
B SULFATE OTIC Solution. On July 21, 2020, the Agency withdrew approval
of this ANDA under the written request of the applicant.
6. Warner-Lambert Co., 201 Tabor Rd., Morris Plains, NJ 07950,
notified the Agency that they no longer market the product for ANDA
061652, OXYTETRACYCLINE Capsules. On May 12, 2021, the Agency withdrew
approval of this ANDA under the written request of the applicant.
7. AH Robins Co., 1211 Sherwood Ave., Richmond, VA 23220, notified
the Agency that they no longer market the product for ANDA 061701,
TETRACYCLINE Syrup, 125 mg/5 mL. On May 12, 2021, the Agency withdrew
approval of this ANDA under the written request of the applicant.
8. Warner Chilcott, Division of Warner Lambert-Pfizer, Inc., 235
East 42nd St., New York, NY 10017, notified the Agency that they no
longer market the products for ANDA 061725, TETRACYCLINE HCl Capsules,
250 mg and 500 mg, and ANDA 062175, TETRACYCLINE HCl Capsules, 250 mg.
On July 21, 2020, the Agency withdrew approval of these ANDAs under the
written request of the applicant.
9. Lederle Laboratories, Division of American Cyanamid Co., 1
Cyanamid Plaza, Wayne, NJ 07470, notified the Agency that they no
longer market the products for ANDA 061943, CHLORAMPHENICOL Ophthalmic
Solution, 0.5 percent; ANDA 062215, OXYTETRACYCLINE HCl Capsules. On
July 21, 2020, the Agency withdrew approval of these ANDAs under the
written request of the applicant.
10. Warner-Lambert Co. notified the Agency that they no longer
market the product for ANDA 062032, EYPAR (erythromycin stearate)
Tablets, EQ 250 mg base and EQ 500 mg base. On May 12, 2021, the Agency
withdrew approval of this ANDA under the written request of the
applicant.
11. Becton Dickinson and Co., Surgical System, 9450 South State
St., Sandy, UT 84070, notified the Agency that they no longer market
the product for ANDA 073416, E-Z SCRUB (chlorhexidine gluconate)
Topical Sponge, 4 percent. On January 8, 2020 (85 FR 909), the Agency
withdrew approval of this ANDA under the written request of the
applicant.
12. Lederle Laboratories, Division of American Cyanamid Co., Pearl
River, NY 10965-1215, notified the Agency that they no longer market
the products for ANDA 083001, TRIAMCINOLONE ACETONIDE Aerosol Foam
Emulsion. On May 12, 2021, the Agency withdrew approval of this ANDA
under the written request of the applicant.
13. Lederle Laboratories, Division of American Cyanamid Co., Pearl
River, NY 10965-1215, notified the Agency that they no longer market
the product for ANDA 084803, CHLORPROMAZINE HCl Tablets, 10 mg. On May
12, 2021, the Agency withdrew approval of this ANDA under the written
request of the applicant.
V. Previously Withdrawn Applications
In the Federal Register of September 25, 2020 (85 FR 60474), FDA
published a separate notice offering an opportunity for a hearing
(NOOH) on a proposal to withdraw approval of ANDAs because the holders
of those ANDAs had repeatedly failed to submit the required annual
reports and have failed to satisfy the requirement to have an approved
risk evaluation and mitigation strategy for the following ANDAs:
1. Everylife, 2021 15th Avenue West, Seattle, WA 98119: ANDA
085217, ACETAMINOPHEN and CODEINE PHOSPHATE Tablet, 325 mg/30 mg.
2. Scherer Laboratories, Inc., 2301 Ohio Dr., Suite 234, Plano, TX
75093: ANDA 085638, ACETAMINOPHEN, ASPIRIN, and CODEINE, 150 mg/180 mg/
60 mg; ANDA 085639, ACETAMINOPHEN, ASPIRIN, and CODEINE PHOSPHATE
Capsule, 150 mg/180 mg/30 mg; ANDA 085640, ACETAMINOPHEN, ASPIRIN, and
CODEINE PHOSPHATE Capsule, 150 mg/180 mg/15 mg.
The holders of the applications did not respond to the Federal
Register NOOH of September 25, 2020. Failure to submit a written notice
of participation and request for hearing as required by Sec. 314.200
constitutes an election by those holders not to make use of the
opportunity for a hearing concerning the proposal to withdraw approval
of their ANDAs and a waiver of any contentions concerning the legal
status of the drug products. On April 9, 2021 (86 FR 18542), the Agency
withdrew approval of these ANDAs.
VI. No Response to NOOH Received
The holders of the other 216 applications did not respond to the
NOOH. Failure to submit a written notice of participation and request
for hearing as required by Sec. 314.200 constitutes an election by
those holders not to make use of the opportunity for a hearing
concerning the proposal to withdraw approval of their ANDAs and a
waiver of any contentions concerning the legal status of the drug
products. Therefore, the Director, Center for Drug Evaluation and
Research, is withdrawing approval of the 216 applications listed in
table 1.
[[Page 58677]]
Table 1--Approved ANDAs for Which Required Reports Have Not Been
Submitted
------------------------------------------------------------------------
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 mg/
100 mL; 1.5 grams
(g)/100 mL; 5.08 mg/
100 mL; 538 mg/100
mL; 448 mg/100 mL.
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 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 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 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 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 061674............... Penicillin V Leiner Health
Potassium Tablets. Products, Inc.
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 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.
[[Page 58678]]
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 062085............... Tetracycline HCl MM Mast and Co., 4152
Capsules, 250 mg. Ruple Rd.,
Cleveland, OH 44121.
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 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 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 072255............... Microderm Johnson and Johnson
(chlorhexidine Medical, Inc., 2500
gluconate) Topical Arbrook Blvd.,
Solution, 4%. Arlington, TX 76014.
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 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 075181............... Prednisolone Sodium WE Pharmaceuticals,
Phosphate Oral Inc.
Solution, EQ 5 mg
base/5 mL.
[[Page 58679]]
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
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 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.
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.
[[Page 58680]]
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 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 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
Aerolate JR 63026.
(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 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.
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 HCl Camall Co., Inc.,
Chewable Tablets. 60950 Van Dyke Ave.,
P.O. Box 218,
Washington, MI
48094.
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 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 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.
[[Page 58681]]
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.
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.
------------------------------------------------------------------------
FDA finds that the holders of the ANDAs listed in table 1 have
repeatedly failed to submit reports required by Sec. Sec. 314.81 and
314.98. In addition, under Sec. 314.200, FDA finds that the holders of
the ANDAs have waived any contentions concerning the legal status of
the drug products. Therefore, under these findings, approval of the
ANDAs listed in table 1 and all amendments and supplements thereto, is
hereby withdrawn, effective October 22, 2021.
Dated: October 19, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23075 Filed 10-21-21; 8:45 am]
BILLING CODE 4164-01-P
