Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications
Federal Register, Volume 81 Issue 192 (Tuesday, October 4, 2016)
Federal Register Volume 81, Number 192 (Tuesday, October 4, 2016)
Notices
Pages 68427-68432
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2016-23893
Page 68427
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2016-N-0002
Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 44 new drug applications (NDAs) and 158 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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: November 3, 2016.
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 under 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 005264............. Heparin Sodium Hospira, Inc., 275
Injection. North Field Dr.,
Bldg. H2-2, Lake
Forest, IL 60045-
5046.
NDA 009470............. Xylocaine Viscous Fresenius Kabi USA
(lidocaine LLC, Three Corporate
hydrochloride (HCl)) Dr., Lake Zurich, IL
Solution. 60047.
NDA 009698............. Miltown (meprobamate) Meda Pharmaceuticals,
Tablets, 200 Inc., 265 Davidson
milligrams (mg) and Ave., Suite 300,
400 mg. Somerset, NJ 08873-
4120.
NDA 009939............. Senokot Granules Purdue Products, L.P.,
(sennosides), 15 mg. One Stamford Forum,
Stamford, CT 06901.
NDA 010382............. Tempra (acetaminophen) Bristol-Myers Squibb
Syrup, 160 mg/5 Co., P.O. Box 4000,
milliliters (mL). Princeton, NJ 88543-
4000.
NDA 011228............. Liquamar Organon USA Inc.,
(phenprocoumon) Subsidiary of Merck &
Tablets. Co., Inc., 2000
Galloping Hill Rd.,
Kenilworth, NJ 07033.
NDA 011613............. Ionamin (phentermine UCB, Inc., 1950 Lake
resin complex) Park Dr., Smyrna, GA
Capsules, 15 mg and 30 30080.
mg.
NDA 011738............. Numorphan (oxymorphone Endo Pharmaceuticals,
HCl) Suppositories, 5 Inc., 100 Endo Blvd.,
mg. Chadds Ford, PA
19317.
NDA 012365............. Soma Compound Meda Pharmaceuticals,
(carisoprodol and Inc.
aspirin) Tablets.
NDA 012940............. Isordil (isosorbide Valeant International
dinitrate) Sublingual Bermuda, c/o Valeant
Tablets, 2.5 mg, 5 mg, Pharmaceuticals North
and 10 mg. America, LLC, 400
Somerset Corporate
Blvd., Bridgewater,
NJ 08807.
NDA 013483............. Drixoral/Disophrol Merck Consumer Care,
(dexbrompheniramine 556 Morris, Ave.,
maleate and Summit, NJ 07901.
pseudoephedrine
sulfate) Extended-
Release Tablets, 6 mg/
120 mg.
NDA 014005............. Maxibolin Organon USA Inc.
(ethylestrenol)
Tablets.
NDA 017087............. Ethrane (enflurane USP) Baxter Healthcare
Corp., 32650 N.
Wilson Rd., Round
Lake, IL 60073.
NDA 017689............. Methadone HCl Syrup.... Sandoz, Inc., 4700
Sandoz, Dr., Wilson,
NC 27893.
NDA 018766............. Ansaid (flurbiprofen) Pharmacia & Upjohn
Tablets, 50 mg and 100 Co., c/o Pfizer,
mg. Inc., 235 East 42nd
St., New York, NY
10017.
NDA 018812............. Sulfamethoxazole and Teva Pharmaceuticals
Trimethoprim Oral USA, Inc., 1090
Suspension USP, 200 mg/ Horsham Rd., P.O. Box
5 mL and 40 mg/5 mL. 1090, North Wales, PA
19454.
NDA 019304............. Tricor (fenofibrate) AbbVie Inc., 1 N.
Micronized Capsules, Waukegan Rd., Dept.
67 mg, 134 mg, and 200 PA77/Bldg. AP30,
mg. North Chicago, IL
60064.
NDA 019384............. Noroxin (norfloxacin) Merck Sharp & Dohme
Tablets, 400 mg. Corp., 351 North
Sumneytown Pike, P.O.
Box 1000, North
Wales, PA 19454.
NDA 020005............. Cardene SR (nicardipine Chiesi USA, Inc., 1255
HCl) Extended-Release Crescent Green Dr.,
Capsules, 30 mg, 45 Suite 250, Cary, NC
mg, and 60 mg. 27518.
NDA 020073............. Romazicon (flumazenil) Hoffman-LaRoche, Inc.,
Injection. c/o Genetech, Inc., 1
DNA Way MS #241B,
South San Francisco,
CA 94080-4900.
NDA 020084............. Iobenguane Sulfate I- Pharmalucence, 10
131 Injection, 2.3 DeAngelo Dr.,
millicuries. Bedford, MA 01730.
NDA 020107............. Novamine (amino acids) Baxter Healthcare
Injection. Corp.
NDA 020229............. Leustatin (cladribine) Janssen
Injection, 1 mg/mL. Pharmaceuticals Inc.,
920 Route 202 South,
P.O. Box 300,
Raritan, NJ 08869-
0602.
NDA 020251............. Zantac (ranitidine HCl) Glaxo Group Limited,
Effervescent Tablets, England d/b/a
25 mg and 150 mg GlaxoSmithKline, Five
Zantac (ranitidine Moore Dr., P.O. Box
HCl) Effervescent 13398, Research
Granules, 150 mg. Triangle Park, NC
27709.
NDA 020312............. Univasc (moexipril HCl) UCB, Inc.
Tablets, 7.5 mg and 15
mg.
NDA 020346............. Zyrtec (cetirizine HCl) Johnson and Johnson
Syrup, 1 mg/mL. Consumer Inc., McNeil
Consumer Healthcare
Division, 7050 Camp
Hill Rd., Fort
Washington, PA 19034-
2299.
NDA 020410............. Gastromark (ferumoxsil) AMAG Pharmaceuticals,
Oral Suspension. 100 Haydon Ave.,
Lexington, MA 02421.
Page 68428
NDA 020416............. Feridex I.V. Do.
(ferumoxides)
Injection.
NDA 020460............. Cytovene (ganciclovir) Roche Palo Alto LLC, c/
Capsules, 250 mg and o Genentech, Inc., 1
500 mg. DNA Way, MS#241B,
South San Francisco,
CA 94080-4990.
NDA 020575............. DentiPatch (lidocaine). Noven Pharmaceuticals,
Inc., 11960 SW. 144th
St., Miami, FL 33186.
NDA 020638............. Vistide (cidofovir) Gilead Sciences, Inc.,
Injection, Equivalent 333 Lakeside Dr.,
to (EQ) 75 mg base/mL. Foster City, CA
94404.
NDA 020729............. Uniretic (moexipril HCl UCB, Inc.
and
hydrochlorothiazide)
Tablets, 7.5 mg/12.5
mg, 15 mg/12.5 mg, and
15 mg/25 mg.
NDA 021044............. Palladone Rhodes Pharmaceuticals
(hydromorphone HCl) L.P., 498 Washington
Extended-Release St., Coventry, RI
Capsules. 02816.
NDA 021046............. Celexa (citalopram Forest Laboratories,
hydrobromide) EQ 10 mg Inc., Harborside
base/5 mL Oral Financial Center,
Solution. Plaza V, Suite 1900,
Jersey, City, NJ
07311.
NDA 021378............. Combunox (Oxycodone HCl Do.
and Ibuprofen) Tablets.
NDA 021671............. DepoDur (morphine Pacira
sulfate) Extended- Pharmaceuticals,
Release Injection. Inc., 10450 Science
Center Dr., San
Diego, CA 92121.
NDA 021693............. Rybix ODT (tramadol Shionogi, Inc., 300
HCl) Orally Campus Dr., Suite
Disintegrating Tablets. 300, Florham Park, NJ
07932.
NDA 021768............. Fludeoxyglucose F18 Weill Medical College
(FDG) Injection. of Cornell
University, c/o
Citigroup Biomedical
Imaging Center, 516
East 72nd St., New
York, NY 10021.
NDA 022244............. Lusedra (fospropofol Eisai, Inc., 155 Tice
disodium) Injection. Blvd., Woodcliff
Lake, NJ 07677.
NDA 022312............. Docetaxel Injection.... Apotex Inc., c/o
Apotex Corp., 2400
North Commerce
Parkway, Suite 400,
Weston, FL 33326.
ANDA 040223............ Acetaminophen and Barr Laboratories,
Codeine Phosphate Inc., Subsidiary of
Tablets USP, 300 mg/15 Teva Pharmaceuticals
mg, 300 mg/30 mg, and USA, Inc., 425 Privet
300 mg/60 mg. Rd., Horsham, PA
19044.
ANDA 040297............ Estradiol Tablets USP, Upsher-Smith
0.5 mg, 1 mg, and 2 mg. Laboratories, Inc.,
6701 Evenstad Dr.,
Maple Grove, MN
55369.
ANDA 040311............ Medroxyprogesterone Duramed
Acetate Tablets USP, Pharmaceuticals,
2.5 mg, 5 mg, and 10 Inc., Subsidiary of
mg. Teva Pharmaceuticals
USA Inc., 425 Privet
Rd., Horsham, PA
19044.
ANDA 040318............ Meperidine HCl Tablets Do.
USP, 50 mg and 100 mg.
ANDA 040472............ Dextroamphetamine Teva Pharmaceuticals
Saccharate, USA, Inc., 425 Privet
Amphetamine Aspartate, Rd., Horsham, PA
Dextroamphetamine 19044.
Sulfate, and
Amphetamine Sulfate
Tablets.
NDA 050143............. Chloromycetin Parkedale
(chloramphenicol Pharmaceuticals,
ophthalmic solution Inc., c/o King
USP) Ophthalmic Pharmaceuticals,
Solution. Inc., 501 Fifth St.,
Bristol, TN 37620.
NDA 050156............. Chloromycetin Do.
(chloramphenicol
ophthalmic ointment
USP) Ophthalmic
Ointment, 1%.
NDA 050443............. Blenoxane (bleomycin Bristol-Myers Squibb
sulfate) for Co.
Injection, EQ 15 units
base/vial and 30 units
base/vial.
NDA 050630............. Primaxin (imipenem and Merck, Sharp & Dohme
cilastatin sodium) Corp.
Powder, EQ 500 mg base/
vial; 500 mg/vial and
EQ 750 mg base/vial;
750 mg/vial.
ANDA 060306............ Penicillin G Potassium Teva Pharmaceuticals
Tablets USP. USA, Inc.
ANDA 060307............ Penicillin G Potassium Do.
for Oral Solution USP.
ANDA 061969............ Cephalexin Capsules Ivax Pharmaceuticals,
USP, EQ 250 mg base Inc., Subsidiary of
and EQ 500 mg base. Teva Pharmaceuticals
USA, Inc.
ANDA 062240............ Cloxacillin Sodium Teva Pharmaceuticals
Capsules USP, EQ 250 USA, Inc.
mg base and EQ 500 mg
base.
ANDA 062252............ Oxacillin Sodium for Teva Pharmaceuticals
Oral Solution USP, EQ USA, Inc.
250 mg base/5 mL.
ANDA 062268............ Cloxacillin Sodium for Do.
Oral Solution USP, EQ
125 mg base/5 mL.
ANDA 062653............ Doryx (doxycycline Warner Chilcott Co.,
hyclate) Delayed- LLC, c/o Warner
Release Capsules, EQ Chilcott (US), LLC,
100 mg base. 100 Enterprise Dr.,
Rockaway, NJ 07866.
ANDA 062670............ Nystatin Oral Teva Pharmaceuticals
Suspension USP, USA, Inc.
100,000 units/mL.
ANDA 062683............ Cephradine Capsules Do.
USP, 250 mg and 500 mg.
ANDA 062695............ Cefadroxil Capsules Do.
USP, EQ 500 mg base.
ANDA 062751............ Erythromycin Pledgets Ivax Pharmaceuticals,
USP, 2%. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 062760............ Cephalexin Capsules Teva Pharmaceuticals
USP, EQ 250 mg base. USA, Inc.
ANDA 062761............ Cephalexin Capsules Do.
USP, EQ 500 mg base.
ANDA 062766............ Cefadroxil Capsules Ivax Pharmaceuticals,
USP, EQ 500 mg base. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 062767............ Cephalexin for Oral Teva Pharmaceuticals
Suspension USP, EQ 125 USA, Inc.
mg base/5 mL.
ANDA 062768............ Cephalexin for Oral Do.
Suspension USP, EQ 250
mg base/5 mL.
ANDA 062775............ Cephalexin Capsules Barr Laboratories,
USP, EQ 500 mg base. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 062853............ Amoxicillin Capsules Teva Pharmaceuticals
USP, 250 mg. USA, Inc.
ANDA 062854............ Amoxicillin Capsules Do.
USP, 500 mg.
ANDA 062946............ Amoxicillin for Oral Do.
Suspension USP, 125 mg/
5 mL.
ANDA 063001............ Amoxicillin for Oral Do.
Suspension USP, 250 mg/
5 mL.
Page 68429
ANDA 063018............ Cefazolin Sodium for Do.
Injection USP, EQ 5
grams (g) base/vial
and EQ 10 g base/vial.
ANDA 063027............ Clindamycin HCl Do.
Capsules USP, EQ 75 mg
base.
ANDA 063030............ Amoxicillin Capsules Do.
USP, 250 mg.
ANDA 063031............ Amoxicillin Capsules Do.
USP, 500 mg.
ANDA 064031............ Amoxicillin Chewable Do.
Tablets, 125 mg and
250 mg.
ANDA 064081............ Cefaclor Capsules USP, Do.
EQ 250 mg base and EQ
500 mg base.
ANDA 064145............ Cefaclor Capsules USP, Do.
EQ 250 mg base and EQ
500 mg base.
ANDA 065137............ Clarithromycin Tablets Ivax Pharmaceuticals,
USP, 250 mg and 500 mg. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 070006............ Sulfamethoxazole and Mutual Pharmaceutical
Trimethoprim Tablets Co., Inc., 1100
USP, 400 mg/80 mg. Orthodox St.,
Philadelphia, PA
19124.
ANDA 070007............ Sulfamethoxazole and Do.
Trimethoprim Tablets
USP, 800 mg/160 mg.
ANDA 070232............ Propranolol HCl Tablets Teva Pharmaceuticals
USP, 10 mg. USA, Inc.
ANDA 070234............ Propranolol HCl Tablets Do.
USP, 40 mg.
ANDA 070266............ Indo-Lemmon Do.
(Indomethacin Capsules
USP), 25 mg.
ANDA 070267............ Indo-Lemmon Do.
(Indomethacin Capsules
USP), 50 mg.
ANDA 070469............ Ibuprohn (Ibuprofen Ohm Laboratories,
Tablets USP), 400 mg. Inc., c/o Ranbaxy
Inc., 600 College Rd.
East, Princeton, NJ
08540.
ANDA 070618............ Potassium Chloride Copley Pharmaceutical,
Extended-Release Inc., Subsidiary of
Tablets USP, 8 Teva Pharmaceuticals
milliequivalents. USA, Inc., 425 Privet
Rd., Horsham, PA
19044.
ANDA 070660............ Metoclopramide HCl Mutual Pharmaceutical
Tablets USP, EQ 10 mg Co., Inc.
base.
ANDA 071145............ Ibuprofen Tablets USP.. Ivax Pharmaceuticals,
Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 071146............ Ibuprofen Tablets USP, Do.
600 mg.
ANDA 071184............ Thiothixene HCl Oral Teva Pharmaceuticals
Solution USP, EQ 5 mg USA, Inc.
base/mL.
ANDA 071342............ Indomethacin Capsules Do.
USP, 25 mg.
ANDA 071343............ Indomethacin Capsules Do.
USP, 50 mg.
ANDA 072438............ Fenoprofen Calcium Par Pharmaceutical,
Capsules USP, EQ 300 Inc., One Ram Ridge
mg base. Rd., Spring Valley,
NY 10977.
ANDA 072522............ Fluocinonide Topical Teva Pharmaceuticals
Solution USP, 0.05%. USA, Inc.
ANDA 072600............ Clofibrate Capsules Do.
USP, 500 mg.
ANDA 072692............ Norethindrone and Barr Laboratories,
Ethinyl Estradiol Inc., Subsidiary of
Tablets USP, 0.5 mg/ Teva Pharmaceuticals,
0.035 mg. USA, Inc.
ANDA 072999............ Dopamine HCl Injection Teva Parenteral
USP, 200 mg/5 mL. Medicines, Inc., 425
Privet Rd., Horsham,
PA 19044.
ANDA 073005............ Cinoxacin Capsules USP, Teva Pharmaceuticals
250 mg. USA, Inc.
ANDA 073006............ Cinoxacin Capsules USP, Do.
500 mg.
ANDA 073043............ Baclofen Tablets USP, Do.
10 mg.
ANDA 073044............ Baclofen Tablets USP, Do.
20 mg.
ANDA 073099............ Leucovorin Calcium Pharmachemie B.V.,
Tablets USP, EQ 5 mg Subsidiary of Teva
base. Pharmaceuticals USA,
Inc., 425 Privet Rd.,
Horsham, PA 19044.
ANDA 073101............ Leucovorin Calcium Do.
Tablets USP, EQ 25 mg
base.
ANDA 073141............ Ibuprofen Tablets USP, Teva Pharmaceuticals
200 mg. USA, Inc.
ANDA 073315............ Atenolol Tablets USP, Do.
50 mg.
ANDA 073316............ Atenolol Tablets USP, Do.
100 mg.
ANDA 073343............ Ibuprofen Tablets USP, Do.
400 mg.
ANDA 073344............ Ibuprofen Tablets USP, Do.
600 mg.
ANDA 073345............ Ibuprofen Tablets USP, Do.
800 mg.
ANDA 073515............ Ketoprofen Capsules Do.
USP, 25 mg.
ANDA 073679............ Diflunisal Tablets USP, Do.
250 mg.
ANDA 074067............ Diltiazem HCl Tablets Do.
USP, 30 mg, 60 mg, 90
mg, and 120 mg.
ANDA 074107............ Atenolol and Pliva, Inc.,
Chlorthalidone Tablets Subsidiary of Teva
USP, 50 mg/25 mg and Pharmaceuticals USA,
100 mg/25 mg. Inc., 425 Privet Rd.,
Horsham, PA 19044.
ANDA 074120............ Atenolol Tablets USP, Teva Pharmaceuticals
50 mg and 100 mg. USA, Inc.
ANDA 074123............ Pindolol Tablets USP, 5 G&W Laboratories,
mg and 10 mg. Inc., 111 Coolidge
St., South
Plainfield, NJ 07080.
ANDA 074124............ Ciprofloxacin HCl Barr Laboratories,
Tablets, EQ 250 mg Inc., Subsidiary of
base, EQ 500 mg base, Teva Pharmaceuticals
and EQ 750 mg base. USA, Inc.
ANDA 074143............ Metoprolol Tartrate Teva Pharmaceuticals
Tablets USP, 50 mg and USA, Inc.
100 mg.
ANDA 074216............ Naproxen Tablets, 250 Do.
mg, 375 mg, and 500 mg.
ANDA 074294............ Alprazolam Tablets USP, Ivax Pharmaceuticals,
0.25 mg, 0.5 mg, 1 mg, Inc., Subsidiary of
and 2 mg. Teva Pharmaceuticals
USA, Inc.
ANDA 074333............ Metoprolol Tartrate Teva Pharmaceuticals
Tablets USP, 50 mg and USA, Inc.
100 mg.
ANDA 074357............ Trazodone HCl Tablets Do.
USP, 150 mg.
ANDA 074365............ Cimetidine Tablets USP, Do.
200 mg, 300 mg, 400
mg, and 800 mg.
Page 68430
ANDA 074446............ Terazosin HCl Tablets, Do.
EQ 1 mg base, EQ 2 mg
base, EQ 5 mg base,
and EQ 10 mg base.
ANDA 074459............ Diclofenac Sodium Do.
Delayed-Release
Tablets USP, 25 mg, 50
mg, and 75 mg.
ANDA 074476............ Hydroxyurea Capsules Roxane Laboratories,
USP, 500 mg. Inc., 1809 Wilson
Rd., Columbus, OH
43228.
ANDA 074504............ Tamoxifen Citrate Teva Pharmaceuticals
Tablets USP, EQ 10 mg USA, Inc.
base and EQ 20 mg base.
ANDA 074537............ Selegiline HCl Tablets G&W Laboratories, Inc.
USP, 5 mg.
ANDA 074555............ Cholestyramine for Oral Teva Pharmaceuticals,
Suspension USP. USA, Inc.
ANDA 074674............ Acyclovir Capsules USP, Ivax Pharmaceuticals,
200 mg. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 074745............ Megestrol Acetate Teva Pharmaceuticals
Tablets USP, 40 mg. USA, Inc.
ANDA 074771............ Cholestyramine for Oral Do.
Suspension USP.
ANDA 074847............ Etodolac Tablets USP, Do.
400 mg and 500 mg.
ANDA 074883............ Etodolac Tablets USP, Ivax Pharmaceuticals,
400 mg and 500 mg. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 074895............ Amiodarone HCl Tablets, Teva Pharmaceuticals
200 mg. USA, Inc.
ANDA 074914............ Acyclovir Capsules USP, Do.
200 mg.
ANDA 074989............ Labetalol HCl Tablets Do.
USP, 100 mg, 200 mg,
and 300 mg.
ANDA 075021............ Acyclovir Tablets USP, Do.
400 mg and 800 mg.
ANDA 075557............ Ranitidine HCl Do.
Capsules, EQ 150 mg
base and EQ 300 mg
base.
ANDA 075686............ Bisoprolol Fumarate and Do.
Hydrochlorothiazide
Tablets USP, 2.5 mg/
6.25 mg, 5 mg/6.25 mg,
and 10 mg/6.25 mg.
ANDA 075719............ Sertraline HCl Tablets Do.
USP, EQ 25 mg base, EQ
50 mg base, and EQ 100
mg base.
ANDA 075726............ Pemoline Tablets, 18.75 Mallinckrodt Inc., 675
mg, 37.5 mg, and 75 mg. McConnell Blvd.,
Hazelwood, MO 63042.
ANDA 075740............ Tamoxifen Citrate Ivax Pharmaceuticals,
Tablets USP, EQ 10 mg Inc., Subsidiary of
base and EQ 20 mg base. Teva Pharmaceuticals
USA, Inc.
ANDA 075810............ Fluoxetine HCl Tablets Barr Laboratories,
, EQ 10 mg base. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 075823............ Calcitriol Injection Teva Parenteral
USP, 0.001 mg/mL and Medicines, Inc.
0.002 mg/mL.
ANDA 075827............ Gabapentin Tablets USP, Teva Pharmaceuticals
600 mg and 800 mg. USA, Inc.
ANDA 075862............ Levonorgestrel and Barr Laboratories,
Ethinyl Estradiol Inc., Subsidiary of
Tablets USP, 0.1 mg/ Teva Pharmaceuticals
0.02 mg. USA, Inc.
ANDA 075865............ Fluoxetine HCl Tablets Ivax Pharmaceuticals,
, EQ 10 mg base and EQ Inc., Subsidiary of
40 mg base. Teva Pharmaceuticals
USA, Inc.
ANDA 075971............ Metformin HCl Tablets Barr Laboratories,
USP, 500 mg, 850 mg, Inc., Subsidiary of
and 1 g. Teva Pharmaceuticals
USA, Inc.
ANDA 075975............ Metformin HCl Tablets Ivax Pharmaceuticals,
USP, 500 mg, 625 mg, Inc., Subsidiary of
750 mg, 850 mg, and 1 Teva Pharmaceuticals
g. USA, Inc.
ANDA 076094............ Pergolide Mesylate Do.
Tablets, EQ 0.05 mg
base, EQ 0.25 mg base,
and EQ 1 mg base.
ANDA 076184............ Alendronate Sodium Teva Pharmaceuticals
Tablets USP, EQ 35 mg USA, Inc.
tablets and EQ 70 mg
tablets.
ANDA 076198............ Balziva-21 Tablets Barr Laboratories,
(norethindrone and Inc., Subsidiary of
ethinyl estradiol Teva Pharmaceuticals
tablets USP), 0.4 mg/ USA, Inc.
0.035 mg.
ANDA 076244............ Mirtazapine Tablets Ivax Pharmaceuticals,
USP, 15 mg, 30 mg, and Inc., Subsidiary of
45 mg. Teva Pharmaceuticals
USA, Inc.
ANDA 076251............ Fluoxetine HCl Barr Laboratories,
Capsules, EQ 40 mg Inc., Subsidiary of
base. Teva Pharmaceuticals
USA, Inc.
ANDA 076328............ Metformin HCl Tablets Teva Pharmaceuticals
USP, 500 mg, 850 mg, USA, Inc.
and 1 g.
ANDA 076340............ Finasteride Tablets Ivax Pharmaceuticals,
USP, 5 mg. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 076426............ Ciprofloxacin HCl Pliva, Inc.,
Tablets , EQ 100 mg Subsidiary of Teva
base, EQ 250 mg base, Pharmaceuticals USA,
EQ 500 mg base, and EQ Inc.
750 mg base.
ANDA 076496............ Metformin HCl Extended- Barr Pharmaceuticals,
Release Tablets USP, Inc., Subsidiary of
500 mg. Teva Pharmaceuticals
USA, Inc.
ANDA 076545............ Metformin HCl Extended- Ivax Pharmaceuticals,
Release Tablets USP, Inc., Subsidiary of
500 mg. Teva Pharmaceuticals
USA, Inc.
ANDA 076840............ Sumatriptan Succinate Teva Pharmaceuticals
Tablets, EQ 25 mg USA, Inc.
base, EQ 50 mg base,
and EQ 100 mg base.
ANDA 076880............ Nicotine Polacrilex Gum Ivax Pharmaceuticals,
USP, EQ 2 mg base. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 076945............ Fosinopril Sodium and Teva Pharmaceuticals
Hydrochlorothiazide USA, Inc.
Tablets USP, 10 mg/
12.5 mg and 20 mg/12.5
mg.
ANDA 077020............ Cilostazol Tablets USP, Ivax Pharmaceuticals,
100 mg. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 077082............ Paroxetine Tablets USP, Teva Pharmaceuticals
EQ 10 mg base, EQ 20 USA, Inc.
mg base, EQ 30 mg
base, and EQ 40 mg
base.
Page 68431
ANDA 077775............ Fentanyl Extended- Noven,
Release Film, 25 Pharmaceuticals, Inc.
micrograms (mcg), 50
mcg, 75 mcg, and 100
mcg.
ANDA 077850............ Nicotine Polacrilex Gum Ivax Pharmaceuticals,
USP, EQ 4 mg base. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 077898............ Cilostazol Tablets USP, Pliva Hrvatska DOO, c/
50 mg and 100 mg. o Teva
Pharmaceuticals USA,
Inc.,425 Privet Rd.,
Horsham, PA 19044.
ANDA 077973............ Bicalutamide Tablets Synthon
USP, 50 mg. Pharmaceuticals,
Inc., 9000
Development Dr., P.O.
Box 110487, Research
Triangle Park, NC
27709.
ANDA 077995............ Bicalutamide Tablets Kudco Ireland Limited,
UPS, 50 mg. c/o Kremers Urban
Pharmaceuticals,
Inc., 1101 C Ave.
West, Seymour, IN
47274.
ANDA 078079............ Ciclopirox Topical Teva Pharmaceuticals
Solution USP, 8%. USA, Inc.
ANDA 078221............ Granisetron HCl Tablets Barr Laboratories,
USP, EQ 1 mg base. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 078263............ Perindopril Erbumine Lupin Limited, c/o
Tablets, 2 mg, 4 mg, Lupin
and 8 mg. Pharmaceuticals,
Inc., 111 South
Calvert St.,
Harborplace Tower,
21st Floor,
Baltimore, MD 21202.
ANDA 078567............ Ciclopirox Topical Mylan Pharmaceuticals
Solution USP, 8%. Inc., 781 Chestnut
Ridge Rd., P.O. Box
4310, Morgantown, WV
26504.
ANDA 078666............ Levonorgestrel Tablets, Watson Laboratories,
0.75 mg. Inc., 311 Bonnie
Circle, Corona, CA
92880.
ANDA 078773............ Atorvastatin Calcium Teva Pharmaceuticals
Tablets, EQ 10 mg USA, Inc.
base, EQ 20 mg (base),
EQ 40 mg base, and EQ
80 mg base.
ANDA 080400............ Hydrocortisone Cream Do.
USP.
ANDA 080828............ Hydrocortisone Acetate Fera Pharmaceuticals
Ophthalmic Ointment LLC, 134 Birch Hill
USP, 0.5%. Rd., Locust Valley,
NY 11560.
ANDA 083919............ Meprobamate Tablets Meda Pharmaceuticals
USP, 600 mg. Inc., 265 Davidson
Ave., Suite 400,
Somerset, NJ 08873.
ANDA 085022............ Hydrochlorothiazide Ivax Pharmaceuticals,
Tablets USP, 100 mg. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 085855............ A-Methapred Hospira, Inc.
(methylprednisolone
sodium succinate for
Injection USP), EQ 125
mg base/vial.
ANDA 086750............ Ergotamine Tartrate Organon USA, Inc.
Sublingual Tablets
USP, 2 mg.
ANDA 087014............ Orgatrax (hydroxyzine Do.
HCl Injection USP), 25
mg/mL and 50 mg/mL.
ANDA 087264............ Thioridazine HCl Mutual Pharmaceutical
Tablets USP, 25 mg. Co., Inc.
ANDA 087665............ Sulfinpyrazone Tablets Barr Pharmaceuticals,
USP, 100 mg. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 087666............ Sulfinpyrazone Capsules Do.
USP, 200 mg.
ANDA 087760............ Hydroxyzine Pamoate Ivax Pharmaceuticals,
Capsules USP, EQ 50 mg Inc., Subsidiary of
HCl. Teva Pharmaceuticals
USA, Inc.
ANDA 087761............ Hydroxyzine Pamoate Do.
Capsules USP, EQ 25 mg
HCl.
ANDA 088370............ Thioridazine HCl Mutual Pharmaceutical
Tablets USP, 50 mg. Co., Inc.
ANDA 088375............ Thioridazine HCl Do.
Tablets USP, 10 mg.
ANDA 088379............ Thioridazine HCl Do.
Tablets USP, 100 mg.
ANDA 088469............ Dexamethasone Sodium Fresenius Kabi USA,
Phosphate Injection LLC.
USP, EQ 10 mg
Phosphate/mL.
ANDA 088900............ Doxylamine Succinate Copley
Tablets USP, 25 mg. Pharmaceuticals,
Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 088902............ Chlorthalidone Tablets Barr Laboratories,
USP, 25 mg. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 088903............ Chlorthalidone Tablets Do.
USP, 50 mg.
ANDA 088974............ Procainamide HCl ANI Pharmaceuticals,
Extended-Release Inc.,.
Tablets USP, 500 mg.
ANDA 089109............ Promethazine HCl Teva Pharmaceuticals
Tablets USP, 25 mg. USA, Inc.
ANDA 090299............ Melphalan HCl for Mylan Institutional
Injection, EQ 50 mg LLC, 4901 Hiawatha
base/vial. Dr., Rockford, IL
61103.
ANDA 090924............ Ibutilide Fumarate Do.
Injection, 0.1 mg/mL.
ANDA 091242............ Anastrozole Tablets Impax Laboratories,
USP, 1 mg. Inc., 30831 Huntwood
Ave., Hayward, CA
94544.
ANDA 091638............ Letrozole Tablets USP, Do.
2.5 mg.
ANDA 200792............ Oxymorphone HCl Par Pharmaceutical,
Extended-Release Inc.
Tablets, 5 mg, 7.5 mg,
10 mg, 15 mg, 20 mg,
30 mg, and 40 mg.
ANDA 204538............ Zidovudine Injection Liaoning Chengda
USP, 10 mg/mL. Biotechnology Co.,
Ltd., c/o Ruby
Pharma, Inc., 116
Village Blvd, Suite
200, Princeton, NJ
08540.
------------------------------------------------------------------------
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 November 3, 2016. Introduction or delivery for introduction into interstate
Page 68432
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: September 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
FR Doc. 2016-23893 Filed 10-3-16; 8:45 am
BILLING CODE 4164-01-P
