Mallinckrodt Inc. et al.; Withdrawal of Approval of 23 New Drug Applications and 68 Abbreviated New Drug Applications, 72186-72188 [2014-28541]
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72186
Federal Register / Vol. 79, No. 234 / Friday, December 5, 2014 / Notices
applicant to assess whether they
provide safety protections comparable
to those in the applicable REMS
ETASU. When the Agency has
determined that comparable protections
existed, FDA has issued letters to the
RLD sponsor stating so, and indicating
that FDA would not consider it to be a
violation of the REMS for the RLD
sponsor to provide drug product to the
prospective ANDA applicant or its
agent.
Requesting or obtaining such a letter
from FDA is not a legal requirement. If
a prospective ANDA applicant chooses
to request such a letter, this guidance is
intended to clarify the process for doing
so.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on how a prospective
generic applicant can obtain a letter
stating that its BE study protocols
contain safety protections comparable to
those in the applicable REMS for the
RLD. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public.
II. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
ACTION:
III. The Paperwork Reduction Act of
1995
SUMMARY:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of 23 new drug applications
(NDAs) and 68 abbreviated new drug
applications (ANDAs) from multiple
applicants. The holders of the
applications notified the Agency in
writing that the drug products were no
longer marketed and requested that the
approval of the applications be
withdrawn.
This guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget under the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501–3520). The collections of
information in 21 CFR parts 312 and
314 have been approved under OMB
control numbers 0910–0014 and 0910–
0001.
DATES:
IV. Electronic Access
FOR FURTHER INFORMATION CONTACT:
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://www.
regulations.gov.
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248,
Silver Spring, MD 20993–0002, 301–
796–3601.
Dated: December 1, 2014.
Leslie Kux,
Associate Commissioner for Policy.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2014–28540 Filed 12–4–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1795]
Mallinckrodt Inc. et al.; Withdrawal of
Approval of 23 New Drug Applications
and 68 Abbreviated New Drug
Applications
AGENCY:
Effective Date: January 5, 2015.
The
holders of the applications listed in
table 1 in this document have informed
FDA that these drug products are no
longer marketed and have requested that
FDA withdraw approval of the
applications pursuant to the process in
§ 314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests,
waived their opportunity for a hearing.
Withdrawal of approval of an
application or abbreviated application
under § 314.150(c) is without prejudice
to refiling.
Food and Drug Administration,
HHS.
TABLE 1
Application No.
Drug
Applicant
NDA 002852 ......
Plexofer (multivitamins) Syrup .................................................
NDA 008719 ......
Levo-Dromoran (levorphanol tartrate) Injection, 2 milligrams
(mg)/milliliter (mL).
Levo-Dromoran (levorphanol tartrate) Tablets, 2 mg ..............
Sodium Phosphate P 32 Solution ............................................
Soma Compound with Codeine (carisoprodol, aspirin, and
codeine phosphate).
Diutensen-R (methyclothiazide and reserpine) Tablets, 2.5
mg/0.1 mg.
Vercyte (pipobroman) Tablets ..................................................
Mallinckrodt Inc., 675 McDonnell Blvd., Hazelwood, MO
63042.
Valeant Pharmaceuticals North America LLC, 400 Somerset
Corporate Blvd., Bridgewater, NJ 08807.
Do.
Mallinckrodt Inc.
Meda Pharmaceuticals Inc., 265 Davidson Ave., Suite 300,
Somerset, NJ 08873–4120.
Do.
NDA 008720 ......
NDA 011777 ......
NDA 012366 ......
NDA 012708 ......
wreier-aviles on DSK5TPTVN1PROD with NOTICES
NDA 016245 ......
NDA 017463 ......
NDA 018310 ......
NDA 018340 ......
NDA 018731 ......
NDA 019453 ......
VerDate Sep<11>2014
Motrin (ibuprofen) Tablets, 300 mg, 400 mg, 600 mg, and
800 mg.
Lymphazurin (isosulfan blue), 1% ............................................
Aerobid (flunisolide) Inhalation Aerosol 1 .................................
Buspar (buspirone hydrochloride (HCl)) Tablets, 5 mg, 10
mg, 15 mg, and 30 mg.
Drixoral (dexbrompheniramine maleate, pseudoephedrine
sulfate, and acetaminophen) Extended-Release Tablets, 3
mg, 60 mg, and 500 mg.
15:07 Dec 04, 2014
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AbbVie, Inc., 1 North Waukegan Rd., Dept. PA 77/Bldg.
AP30, North Chicago, IL 60064.
McNeil Consumer Healthcare Division of McNeil-PPC, Inc.,
7050 Camp Hill Rd., Fort Washington, PA 19034–2299.
Covidien, 60 Middletown Ave., North Haven, CT 06473.
Roche Palo Alto LLC, c/o Genentech Inc., 1 DNA Way,
South San Francisco, CA 94080–4990.
Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ
08543–4000.
Merck Consumer Care, 556 Morris Ave., Summit, NJ 07901.
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Federal Register / Vol. 79, No. 234 / Friday, December 5, 2014 / Notices
72187
TABLE 1—Continued
Application No.
Drug
NDA 019842 ......
NDA 020150 ......
Motrin (ibuprofen) Suspension, 100 mg/5 mL .........................
Nicotrol TD (nicotine transdermal system), 5 mg/16 hour (hr),
10 mg/16 hr, and 15 mg/16 hr.
Skelid (tiludronate disodium) Tablets .......................................
NDA 020707 ......
NDA 021043 ......
NDA 021082 ......
NDA 021190 ......
NDA 021335 ......
NDA 021745 ......
NDA 022217 ......
NDA 022470 ......
ANDA 040034 ....
ANDA 040052 ....
ANDA 040365 ....
ANDA 040367 ....
ANDA 060578 ....
ANDA 062162 ....
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
062256
062773
062850
062851
062858
062859
063016
RID Mousse (pyrethrins 0.33% and piperonyl butoxide 4.0%)
Topical Aerosol.
Tavist Allergy Sinus Headache (clemastine fumarate,
pseudoephedrine HCl, and acetaminophen) Tablets, 0.335
mg, 30 mg, and 500 mg.
Buspar (buspirone HCl) Capsules, 5 mg, 7.5 mg, 10 mg, and
15 mg.
Gleevac (imatinib mesylate) Capsules, 50 mg and 100 mg ...
Ryzolt (tramadol HCl) Extended-Release Tablets, 100 mg,
200 mg, and 300 mg.
Valturna (aliskiren and valsartan) Tablets ...............................
Nexcede (ketoprofen) Oral Soluble Films, 12.5 mg ................
Theophylline Extended-Release Tablets, 450 mg ...................
Theophylline Extended-Release Capsules, 100 mg, 125 mg,
200 mg, and 300 mg.
Dextroamphetamine Sulfate Tablets, 5 mg .............................
Dextroamphetamine Sulfate Tablets, 10 mg ...........................
Mycostatin Topical Powder (nystatin topical powder USP)
100,000 units/gram (g).
Erythromycin Estolate Capsules USP, 125 mg and 250 mg ..
ANDA 063028 ....
Erythromycin Ethylsuccinate Tablets USP, 400 mg ................
Cephalexin Capsules USP 250 mg .........................................
Cephradine Capsules USP 250 mg .........................................
Cephradine Capsules USP 500 mg .........................................
Cephradine for Oral Suspension USP 125 mg/5 mL ..............
Cephradine for Oral Suspension USP, 250 mg/5 mL .............
Cefazolin for Injection USP 250 mg/vial, 500 mg/vial, and 1
g/vial.
Erythromycin Delayed-Release Tablets USP, 333 mg ............
ANDA 063086 ....
ANDA 063098 ....
ANDA 063179 ....
Erythromycin Delayed-Release Tablets, 333 mg ....................
Erythromycin Delayed-Release Capsules USP, 250 mg ........
Erythromycin Stearate Tablets USP 500 mg ...........................
ANDA
ANDA
ANDA
ANDA
Cefuroxime for Injection USP 7.5 g/vial ...................................
Cefuroxime for Injection USP 750 mg/vial and 1.5 g/vial ........
Doxycycline Capsules USP 50 mg and 100 mg .....................
Ceftriaxone for Injection USP, 250 mg/vial, 500 mg/vial, 1 g/
vial, and 2 g/vial.
Ceftriaxone for Injection USP, 1 g/vial and 2 g/vial .................
Ceftriaxone for Injection USP, 10 g/vial ...................................
Sulfamethoxazole and Trimethoprim Tablets USP 400 mg/80
mg.
Sulfamethoxazole and Trimethoprim Tablets USP 800 mg/
160 mg.
Indomethacin Extended-Release Capsules, 75 mg ................
064191
064192
065032
065227
....
....
....
....
....
....
....
Applicant
....
....
....
....
ANDA 065262 ....
ANDA 065274 ....
ANDA 070034 ....
ANDA 070216 ....
wreier-aviles on DSK5TPTVN1PROD with NOTICES
ANDA 072410 ....
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
072499
072500
072501
072502
072619
072620
073095
073531
....
....
....
....
....
....
....
....
ANDA 073532 ....
ANDA 073667 ....
ANDA 074043 ....
VerDate Sep<11>2014
Propranolol HCl Extended-Release Capsules, 60 mg ............
Propranolol HCl Extended-Release Capsules, 80 mg ............
Propranolol HCl Extended-Release Capsules, 120 mg ..........
Propranolol HCl Extended-Release Capsules, 160 mg ..........
Albuterol Sulfate Tablets USP 2 mg ........................................
Albuterol Sulfate Tablets USP 4 mg ........................................
Clemastine Fumerate Syrup, 0.5 mg/5 mL ..............................
Potassium Chloride Extended-Release Capsules USP, 8
milliequivalents (mEq).
Potassium Chloride Extended-Release Capsules USP, 10
mEq.
Nortriptyline HCl Capsules, 10 mg, 25 mg, 50 mg, and 75
mg.
Piroxicam Capsules USP, 10 mg and 20 mg ..........................
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McNeil Consumer Healthcare Division of McNeil-PPC, Inc.
Do.
Sanofi-Aventis U.S. LLC, 55 Corporate Dr., Mailstop 55C–
205A, Bridgewater, NJ 08807.
Bayer Healthcare LLC, 100 Bayer Blvd., Whippany, NJ
07981–0915.
Novartis Consumer Health, Inc., 200 Kimball Dr., Parsippany,
NJ 07054.
Bristol-Myers Squibb Co.
Novartis Pharmaceuticals Corp., One Health Plaza, East
Hanover, NJ 07936.
Purdue Pharma Products L.P., One Stamford Forum, Stamford, CT 06901–3431.
Novartis Pharmaceuticals Corp.
Novartis Consumer Health, Inc.
Inwood Laboratories, Inc., Subsidiary of Forest Laboratories,
Inc., Harborside Financial Center, Plaza Five, Suite 1900,
Jersey City, NJ 07311.
Do.
Nesher Pharmaceutical (USA) LLC, 13910 Saint Charles
Rock Rd., Bridgeton, MO 63044.
Do.
Delcor Asset Corp., c/o Prestium Pharma Inc., 411 South
State St., Suite E–100, Newtown, PA 18940.
Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677.
Do.
Do.
Do.
Do.
Do.
Do.
Teva Pharmaceuticals USA, 425 Privet Rd., Horsham, PA
19044.
Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA.
Do.
Do.
ANI Pharmaceuticals, Inc., 210 Main St. West, Baudette, MN
56623.
Teva Pharmaceuticals USA.
Do.
Sandoz Inc., 4700 Sandoz Dr., Wilson, NC 27893.
Teva Pharmaceuticals USA.
Do.
Do.
Teva Pharmaceuticals USA.
Barr Laboratories Inc., Subsidiary of Teva Pharmaceuticals.
Inwood Laboratories, Inc., Subsidiary of Forest Laboratories,
Inc.
Do.
Do.
Do.
Do.
Teva Pharmaceuticals USA.
Do.
Do.
Do.
Do.
Do.
Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., P.O.
Box 4310, Morgantown, WV 26505.
E:\FR\FM\05DEN1.SGM
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72188
Federal Register / Vol. 79, No. 234 / Friday, December 5, 2014 / Notices
TABLE 1—Continued
Application No.
Drug
Applicant
Do.
Teva Pharmaceuticals USA.
Do.
Do.
Alkermes Gainesville LLC, 1300 Gould Dr., Gainesville, GA
30504.
Mylan Pharmaceuticals, Inc.
Do.
Do.
Do.
ANDA
ANDA
ANDA
ANDA
ANDA
074126
074589
074828
074849
074879
....
....
....
....
....
Atenolol Tablets USP, 25 mg, 50 mg, and 100 mg ................
Minoxidil Topical Solution, 2% .................................................
Acyclovir Capsules, 200 mg ....................................................
Clomipramine HCl Capsules, 25 mg, 50 mg, and 75 mg .......
Ketoprofen Extended-Release Capsules, 200 mg ..................
ANDA
ANDA
ANDA
ANDA
074976
074977
075161
075472
....
....
....
....
Acyclovir Tablets USP, 400 mg and 800 mg ..........................
Acyclovir Capsules USP, 200 mg ............................................
Ticlopidine HCl Tablets USP, 250 mg .....................................
Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20
mg.
Nizatidine Capsules USP, 150 mg and 300 mg ......................
Quinapril Tablets USP, 5 mg, 10 mg, 20 mg, and 40 mg .......
Metoprolol Succinate Extended-Release Tablets USP, 25
mg, 50 mg, 100 mg, and 200 mg.
Terbinafine HCl Tablets, 250 mg .............................................
Sumatriptan Succinate Tablets, 25 mg, 50 mg, and 100 mg ..
Divalproex Sodium Delayed-Release Tablets USP, 125 mg,
250 mg, and 500 mg.
Glimepiride Tablets USP, 1 mg, 2 mg, and 4 mg ...................
Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/
12.5 mg and 20 mg/12.5 mg.
Meloxicam Tablets USP, 7.5 mg and 15 mg ...........................
Cromolyn Sodium Nasal Solution USP, 5.2 mg/1 spray .........
ANDA 075934 ....
ANDA 076036 ....
ANDA 076969 ....
ANDA 077136 ....
ANDA 077163 ....
ANDA 077254 ....
ANDA 077486 ....
ANDA 077705 ....
ANDA 077934 ....
ANDA 077976 ....
ANDA 078638 ....
ANDA 078731 ....
ANDA
ANDA
ANDA
ANDA
ANDA
079184
081295
084499
084500
085794
....
....
....
....
....
ANDA 085795 ....
ANDA 087176 ....
ANDA 087653 ....
ANDA 088833 ....
ANDA 088896 ....
NDA 202343 ......
Alendronate Sodium Tablets USP, 35 mg and 70 mg ............
Levetiracetam Tablets, 250 mg, 500 mg, 750 mg, and 1,000
mg.
Ursodiol Tablets USP, 250 mg and 500 mg ............................
Estradiol Tablets USP, 0.5 mg ................................................
Estradiol Tablets USP, 1 mg ...................................................
Estradiol Tablets USP, 2 mg ...................................................
Acetaminophen and Codeine Phosphate Tablets USP, 300
mg/30 mg.
Acetaminophen and Codeine Phosphate Tablets USP, 300
mg/15 mg.
Chlorthalidone Tablets USP, 50 mg ........................................
Acetaminophen and Codeine Phosphate Tablets USP, 300
mg/60 mg.
Triprolidine HCl, pseudoephedrine HCl, and Codeine Phosphate Cough Syrup, 1.25 mg/5 mL, 30 mg/5 mL, and 10
mg/5 mL.
Promethazine VC with Codeine (promethazine HCl, phenylephrine HCl, and codeine phosphate) Cough Syrup, 6.25
mg/5 mL, 5 mg/5 mL, and 10 mg/5 mL.
Juvisync (sitagliptin and simvastatin) Tablets, 100 mg/10 mg,
100 mg/20 mg, and 100 mg/40 mg.
Do.
Do.
Sandoz, Inc.
Mylan Pharmaceuticals, Inc.
Do.
Do.
Do.
Do.
Do.
HH & P LLC, c/o Kuker Regulatory Consulting, LLC, 18 Dunbar Way, Mahtomedi, MN 55115.
Mylan Pharmaceuticals, Inc.
Do.
Teva Pharmaceuticals USA.
Bristol-Myers Squibb Co.
Do.
Do.
Mutual Pharmaceutical Co., Inc., 1100 Orthodox St., Philadelphia, PA 19124.
Do.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff Lake,
NJ 07677.
Mutual Pharmaceutical Co., Inc.
Wockhardt Bio AG, c/o Morton Grove Pharmaceuticals, Inc.,
6451 Main St., Morton Grove, IL 60053.
Do.
Merck Sharp & Dohme Corp., 351 North Sumneytown Pike,
P.O. Box 1000, UG2CD–015, North Wales, PA 19454.
wreier-aviles on DSK5TPTVN1PROD with NOTICES
1 This product included an oral pressurized metered-dose inhaler that contained chlorofluorocarbons (CFCs) as a propellant. CFCs may no
longer be used as a propellant for any flunisolide metered-dose inhalers (see 75 FR 19213, April 14, 2010).
Therefore, under section 505(e) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 355(e)) and
under authority delegated to the
Director, Center for Drug Evaluation and
Research, by the Commissioner,
approval of the applications listed in
table 1 in this document, and all
amendments and supplements thereto,
is hereby withdrawn, effective January
5, 2015. Introduction or delivery for
introduction into interstate commerce of
products without approved new drug
applications violates section 301(a) and
(d) of the FD&C Act (21 U.S.C. 331(a)
and (d)). Drug products that are listed in
VerDate Sep<11>2014
15:07 Dec 04, 2014
Jkt 235001
Table 1 that are in inventory on the date
that this notice becomes effective (see
the DATES section) may continue to be
dispensed until the inventories have
been depleted or the drug products have
reached their expiration dates or
otherwise become violative, whichever
occurs first.
Dated: December 1, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–28541 Filed 12–4–14; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
BILLING CODE 4164–01–P
PO 00000
In compliance with Section
3507(a)(1)(D) of the Paperwork
SUMMARY:
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]]>Agencies
[Federal Register Volume 79, Number 234 (Friday, December 5, 2014)]
[Notices]
[Pages 72186-72188]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28541]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1795]
Mallinckrodt Inc. et al.; Withdrawal of Approval of 23 New Drug
Applications and 68 Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 23 new drug applications (NDAs) and 68 abbreviated new drug
applications (ANDAs) from multiple applicants. The holders of the
applications notified the Agency in writing that the drug products were
no longer marketed and requested that the approval of the applications
be withdrawn.
DATES: Effective Date: January 5, 2015.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: The holders of the applications listed in
table 1 in this document have informed FDA that these drug products are
no longer marketed and have requested that FDA withdraw approval of the
applications pursuant to the process in Sec. 314.150(c) (21 CFR
314.150(c)). The applicants have also, by their requests, waived their
opportunity for a hearing. Withdrawal of approval of an application or
abbreviated application under Sec. 314.150(c) is without prejudice to
refiling.
Table 1
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 002852............. Plexofer Mallinckrodt Inc., 675
(multivitamins) Syrup. McDonnell Blvd.,
Hazelwood, MO 63042.
NDA 008719............. Levo-Dromoran Valeant
(levorphanol tartrate) Pharmaceuticals North
Injection, 2 America LLC, 400
milligrams (mg)/ Somerset Corporate
milliliter (mL). Blvd., Bridgewater,
NJ 08807.
NDA 008720............. Levo-Dromoran Do.
(levorphanol tartrate)
Tablets, 2 mg.
NDA 011777............. Sodium Phosphate P 32 Mallinckrodt Inc.
Solution.
NDA 012366............. Soma Compound with Meda Pharmaceuticals
Codeine (carisoprodol, Inc., 265 Davidson
aspirin, and codeine Ave., Suite 300,
phosphate). Somerset, NJ 08873-
4120.
NDA 012708............. Diutensen-R Do.
(methyclothiazide and
reserpine) Tablets,
2.5 mg/0.1 mg.
NDA 016245............. Vercyte (pipobroman) AbbVie, Inc., 1 North
Tablets. Waukegan Rd., Dept.
PA 77/Bldg. AP30,
North Chicago, IL
60064.
NDA 017463............. Motrin (ibuprofen) McNeil Consumer
Tablets, 300 mg, 400 Healthcare Division
mg, 600 mg, and 800 mg. of McNeil-PPC, Inc.,
7050 Camp Hill Rd.,
Fort Washington, PA
19034-2299.
NDA 018310............. Lymphazurin (isosulfan Covidien, 60
blue), 1%. Middletown Ave.,
North Haven, CT
06473.
NDA 018340............. Aerobid (flunisolide) Roche Palo Alto LLC, c/
Inhalation Aerosol \1\. o Genentech Inc., 1
DNA Way, South San
Francisco, CA 94080-
4990.
NDA 018731............. Buspar (buspirone Bristol-Myers Squibb
hydrochloride (HCl)) Co., P.O. Box 4000,
Tablets, 5 mg, 10 mg, Princeton, NJ 08543-
15 mg, and 30 mg. 4000.
NDA 019453............. Drixoral Merck Consumer Care,
(dexbrompheniramine 556 Morris Ave.,
maleate, Summit, NJ 07901.
pseudoephedrine
sulfate, and
acetaminophen)
Extended-Release
Tablets, 3 mg, 60 mg,
and 500 mg.
[[Page 72187]]
NDA 019842............. Motrin (ibuprofen) McNeil Consumer
Suspension, 100 mg/5 Healthcare Division
mL. of McNeil-PPC, Inc.
NDA 020150............. Nicotrol TD (nicotine Do.
transdermal system), 5
mg/16 hour (hr), 10 mg/
16 hr, and 15 mg/16 hr.
NDA 020707............. Skelid (tiludronate Sanofi-Aventis U.S.
disodium) Tablets. LLC, 55 Corporate
Dr., Mailstop 55C-
205A, Bridgewater, NJ
08807.
NDA 021043............. RID Mousse (pyrethrins Bayer Healthcare LLC,
0.33% and piperonyl 100 Bayer Blvd.,
butoxide 4.0%) Topical Whippany, NJ 07981-
Aerosol. 0915.
NDA 021082............. Tavist Allergy Sinus Novartis Consumer
Headache (clemastine Health, Inc., 200
fumarate, Kimball Dr.,
pseudoephedrine HCl, Parsippany, NJ 07054.
and acetaminophen)
Tablets, 0.335 mg, 30
mg, and 500 mg.
NDA 021190............. Buspar (buspirone HCl) Bristol-Myers Squibb
Capsules, 5 mg, 7.5 Co.
mg, 10 mg, and 15 mg.
NDA 021335............. Gleevac (imatinib Novartis
mesylate) Capsules, 50 Pharmaceuticals
mg and 100 mg. Corp., One Health
Plaza, East Hanover,
NJ 07936.
NDA 021745............. Ryzolt (tramadol HCl) Purdue Pharma Products
Extended-Release L.P., One Stamford
Tablets, 100 mg, 200 Forum, Stamford, CT
mg, and 300 mg. 06901-3431.
NDA 022217............. Valturna (aliskiren and Novartis
valsartan) Tablets. Pharmaceuticals Corp.
NDA 022470............. Nexcede (ketoprofen) Novartis Consumer
Oral Soluble Films, Health, Inc.
12.5 mg.
ANDA 040034............ Theophylline Extended- Inwood Laboratories,
Release Tablets, 450 Inc., Subsidiary of
mg. Forest Laboratories,
Inc., Harborside
Financial Center,
Plaza Five, Suite
1900, Jersey City, NJ
07311.
ANDA 040052............ Theophylline Extended- Do.
Release Capsules, 100
mg, 125 mg, 200 mg,
and 300 mg.
ANDA 040365............ Dextroamphetamine Nesher Pharmaceutical
Sulfate Tablets, 5 mg. (USA) LLC, 13910
Saint Charles Rock
Rd., Bridgeton, MO
63044.
ANDA 040367............ Dextroamphetamine Do.
Sulfate Tablets, 10 mg.
ANDA 060578............ Mycostatin Topical Delcor Asset Corp., c/
Powder (nystatin o Prestium Pharma
topical powder USP) Inc., 411 South State
100,000 units/gram (g). St., Suite E-100,
Newtown, PA 18940.
ANDA 062162............ Erythromycin Estolate Barr Laboratories,
Capsules USP, 125 mg Inc., Subsidiary of
and 250 mg. Teva Pharmaceuticals
USA, 400 Chestnut
Ridge Rd., Woodcliff
Lake, NJ 07677.
ANDA 062256............ Erythromycin Do.
Ethylsuccinate Tablets
USP, 400 mg.
ANDA 062773............ Cephalexin Capsules USP Do.
250 mg.
ANDA 062850............ Cephradine Capsules USP Do.
250 mg.
ANDA 062851............ Cephradine Capsules USP Do.
500 mg.
ANDA 062858............ Cephradine for Oral Do.
Suspension USP 125 mg/
5 mL.
ANDA 062859............ Cephradine for Oral Do.
Suspension USP, 250 mg/
5 mL.
ANDA 063016............ Cefazolin for Injection Teva Pharmaceuticals
USP 250 mg/vial, 500 USA, 425 Privet Rd.,
mg/vial, and 1 g/vial. Horsham, PA 19044.
ANDA 063028............ Erythromycin Delayed- Barr Laboratories,
Release Tablets USP, Inc., Subsidiary of
333 mg. Teva Pharmaceuticals
USA.
ANDA 063086............ Erythromycin Delayed- Do.
Release Tablets, 333
mg.
ANDA 063098............ Erythromycin Delayed- Do.
Release Capsules USP,
250 mg.
ANDA 063179............ Erythromycin Stearate ANI Pharmaceuticals,
Tablets USP 500 mg. Inc., 210 Main St.
West, Baudette, MN
56623.
ANDA 064191............ Cefuroxime for Teva Pharmaceuticals
Injection USP 7.5 g/ USA.
vial.
ANDA 064192............ Cefuroxime for Do.
Injection USP 750 mg/
vial and 1.5 g/vial.
ANDA 065032............ Doxycycline Capsules Sandoz Inc., 4700
USP 50 mg and 100 mg. Sandoz Dr., Wilson,
NC 27893.
ANDA 065227............ Ceftriaxone for Teva Pharmaceuticals
Injection USP, 250 mg/ USA.
vial, 500 mg/vial, 1 g/
vial, and 2 g/vial.
ANDA 065262............ Ceftriaxone for Do.
Injection USP, 1 g/
vial and 2 g/vial.
ANDA 065274............ Ceftriaxone for Do.
Injection USP, 10 g/
vial.
ANDA 070034............ Sulfamethoxazole and Teva Pharmaceuticals
Trimethoprim Tablets USA.
USP 400 mg/80 mg.
ANDA 070216............ Sulfamethoxazole and Barr Laboratories
Trimethoprim Tablets Inc., Subsidiary of
USP 800 mg/160 mg. Teva Pharmaceuticals.
ANDA 072410............ Indomethacin Extended- Inwood Laboratories,
Release Capsules, 75 Inc., Subsidiary of
mg. Forest Laboratories,
Inc.
ANDA 072499............ Propranolol HCl Do.
Extended-Release
Capsules, 60 mg.
ANDA 072500............ Propranolol HCl Do.
Extended-Release
Capsules, 80 mg.
ANDA 072501............ Propranolol HCl Do.
Extended-Release
Capsules, 120 mg.
ANDA 072502............ Propranolol HCl Do.
Extended-Release
Capsules, 160 mg.
ANDA 072619............ Albuterol Sulfate Teva Pharmaceuticals
Tablets USP 2 mg. USA.
ANDA 072620............ Albuterol Sulfate Do.
Tablets USP 4 mg.
ANDA 073095............ Clemastine Fumerate Do.
Syrup, 0.5 mg/5 mL.
ANDA 073531............ Potassium Chloride Do.
Extended-Release
Capsules USP, 8
milliequivalents (mEq).
ANDA 073532............ Potassium Chloride Do.
Extended-Release
Capsules USP, 10 mEq.
ANDA 073667............ Nortriptyline HCl Do.
Capsules, 10 mg, 25
mg, 50 mg, and 75 mg.
ANDA 074043............ Piroxicam Capsules USP, Mylan Pharmaceuticals,
10 mg and 20 mg. Inc., 781 Chestnut
Ridge Rd., P.O. Box
4310, Morgantown, WV
26505.
[[Page 72188]]
ANDA 074126............ Atenolol Tablets USP, Do.
25 mg, 50 mg, and 100
mg.
ANDA 074589............ Minoxidil Topical Teva Pharmaceuticals
Solution, 2%. USA.
ANDA 074828............ Acyclovir Capsules, 200 Do.
mg.
ANDA 074849............ Clomipramine HCl Do.
Capsules, 25 mg, 50
mg, and 75 mg.
ANDA 074879............ Ketoprofen Extended- Alkermes Gainesville
Release Capsules, 200 LLC, 1300 Gould Dr.,
mg. Gainesville, GA
30504.
ANDA 074976............ Acyclovir Tablets USP, Mylan Pharmaceuticals,
400 mg and 800 mg. Inc.
ANDA 074977............ Acyclovir Capsules USP, Do.
200 mg.
ANDA 075161............ Ticlopidine HCl Tablets Do.
USP, 250 mg.
ANDA 075472............ Enalapril Maleate Do.
Tablets USP, 2.5 mg, 5
mg, 10 mg, and 20 mg.
ANDA 075934............ Nizatidine Capsules Do.
USP, 150 mg and 300 mg.
ANDA 076036............ Quinapril Tablets USP, Do.
5 mg, 10 mg, 20 mg,
and 40 mg.
ANDA 076969............ Metoprolol Succinate Sandoz, Inc.
Extended-Release
Tablets USP, 25 mg, 50
mg, 100 mg, and 200 mg.
ANDA 077136............ Terbinafine HCl Mylan Pharmaceuticals,
Tablets, 250 mg. Inc.
ANDA 077163............ Sumatriptan Succinate Do.
Tablets, 25 mg, 50 mg,
and 100 mg.
ANDA 077254............ Divalproex Sodium Do.
Delayed-Release
Tablets USP, 125 mg,
250 mg, and 500 mg.
ANDA 077486............ Glimepiride Tablets Do.
USP, 1 mg, 2 mg, and 4
mg.
ANDA 077705............ Fosinopril Sodium and Do.
Hydrochlorothiazide
Tablets, 10 mg/12.5 mg
and 20 mg/12.5 mg.
ANDA 077934............ Meloxicam Tablets USP, Do.
7.5 mg and 15 mg.
ANDA 077976............ Cromolyn Sodium Nasal HH & P LLC, c/o Kuker
Solution USP, 5.2 mg/1 Regulatory
spray. Consulting, LLC, 18
Dunbar Way,
Mahtomedi, MN 55115.
ANDA 078638............ Alendronate Sodium Mylan Pharmaceuticals,
Tablets USP, 35 mg and Inc.
70 mg.
ANDA 078731............ Levetiracetam Tablets, Do.
250 mg, 500 mg, 750
mg, and 1,000 mg.
ANDA 079184............ Ursodiol Tablets USP, Teva Pharmaceuticals
250 mg and 500 mg. USA.
ANDA 081295............ Estradiol Tablets USP, Bristol-Myers Squibb
0.5 mg. Co.
ANDA 084499............ Estradiol Tablets USP, Do.
1 mg.
ANDA 084500............ Estradiol Tablets USP, Do.
2 mg.
ANDA 085794............ Acetaminophen and Mutual Pharmaceutical
Codeine Phosphate Co., Inc., 1100
Tablets USP, 300 mg/30 Orthodox St.,
mg. Philadelphia, PA
19124.
ANDA 085795............ Acetaminophen and Do.
Codeine Phosphate
Tablets USP, 300 mg/15
mg.
ANDA 087176............ Chlorthalidone Tablets Ivax Pharmaceuticals,
USP, 50 mg. Inc., Subsidiary of
Teva Pharmaceuticals
USA, 400 Chestnut
Ridge Rd., Woodcliff
Lake, NJ 07677.
ANDA 087653............ Acetaminophen and Mutual Pharmaceutical
Codeine Phosphate Co., Inc.
Tablets USP, 300 mg/60
mg.
ANDA 088833............ Triprolidine HCl, Wockhardt Bio AG, c/o
pseudoephedrine HCl, Morton Grove
and Codeine Phosphate Pharmaceuticals,
Cough Syrup, 1.25 mg/5 Inc., 6451 Main St.,
mL, 30 mg/5 mL, and 10 Morton Grove, IL
mg/5 mL. 60053.
ANDA 088896............ Promethazine VC with Do.
Codeine (promethazine
HCl, phenylephrine
HCl, and codeine
phosphate) Cough
Syrup, 6.25 mg/5 mL, 5
mg/5 mL, and 10 mg/5
mL.
NDA 202343............. Juvisync (sitagliptin Merck Sharp & Dohme
and simvastatin) Corp., 351 North
Tablets, 100 mg/10 mg, Sumneytown Pike, P.O.
100 mg/20 mg, and 100 Box 1000, UG2CD-015,
mg/40 mg. North Wales, PA
19454.
------------------------------------------------------------------------
\1\ This product included an oral pressurized metered-dose inhaler that
contained chlorofluorocarbons (CFCs) as a propellant. CFCs may no
longer be used as a propellant for any flunisolide metered-dose
inhalers (see 75 FR 19213, April 14, 2010).
Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 355(e)) and under authority
delegated to the Director, Center for Drug Evaluation and Research, by
the Commissioner, approval of the applications listed in table 1 in
this document, and all amendments and supplements thereto, is hereby
withdrawn, effective January 5, 2015. Introduction or delivery for
introduction into interstate commerce of products without approved new
drug applications violates section 301(a) and (d) of the FD&C Act (21
U.S.C. 331(a) and (d)). Drug products that are listed in Table 1 that
are in inventory on the date that this notice becomes effective (see
the DATES section) may continue to be dispensed until the inventories
have been depleted or the drug products have reached their expiration
dates or otherwise become violative, whichever occurs first.
Dated: December 1, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28541 Filed 12-4-14; 8:45 am]
BILLING CODE 4164-01-P
