Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications, 68427-68432 [2016-23893]
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Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices
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.
The Food and Drug
Administration (FDA) is withdrawing
SUMMARY:
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withdrawn.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,
68427
Silver Spring, MD 20993–0002, 301–
796–3601.
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
§ 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.
SUPPLEMENTARY INFORMATION:
TABLE 1
Application No.
Drug
Applicant
NDA 005264 ......
Heparin Sodium Injection .........................................................
NDA 009470 ......
Xylocaine Viscous (lidocaine hydrochloride (HCl)) Solution ....
NDA 009698 ......
NDA 009939 ......
Miltown (meprobamate) Tablets, 200 milligrams (mg) and
400 mg.
Senokot Granules (sennosides), 15 mg ..................................
NDA 010382 ......
Tempra (acetaminophen) Syrup, 160 mg/5 milliliters (mL) .....
NDA 011228 ......
Liquamar (phenprocoumon) Tablets ........................................
NDA 011613 ......
Ionamin (phentermine resin complex) Capsules, 15 mg and
30 mg.
Numorphan (oxymorphone HCl) Suppositories, 5 mg .............
Hospira, Inc., 275 North Field Dr., Bldg. H2–2, Lake Forest,
IL 60045–5046.
Fresenius Kabi USA LLC, Three Corporate Dr., Lake Zurich,
IL 60047.
Meda Pharmaceuticals, Inc., 265 Davidson Ave., Suite 300,
Somerset, NJ 08873–4120.
Purdue Products, L.P., One Stamford Forum, Stamford, CT
06901.
Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ
88543–4000.
Organon USA Inc., Subsidiary of Merck & Co., Inc., 2000
Galloping Hill Rd., Kenilworth, NJ 07033.
UCB, Inc., 1950 Lake Park Dr., Smyrna, GA 30080.
NDA 011738 ......
NDA 012365 ......
NDA 012940 ......
Soma Compound (carisoprodol and aspirin) Tablets ..............
Isordil (isosorbide dinitrate) Sublingual Tablets, 2.5 mg, 5
mg, and 10 mg.
NDA 013483 ......
NDA 014005 ......
NDA 017087 ......
Drixoral/Disophrol
(dexbrompheniramine
maleate
and
pseudoephedrine sulfate) Extended-Release Tablets, 6
mg/120 mg.
Maxibolin (ethylestrenol) Tablets .............................................
Ethrane (enflurane USP) ..........................................................
NDA 017689 ......
NDA 018766 ......
Methadone HCl Syrup ..............................................................
Ansaid (flurbiprofen) Tablets, 50 mg and 100 mg ...................
NDA 018812 ......
Sulfamethoxazole and Trimethoprim Oral Suspension USP,
200 mg/5 mL and 40 mg/5 mL.
Tricor (fenofibrate) Micronized Capsules, 67 mg, 134 mg,
and 200 mg.
Noroxin (norfloxacin) Tablets, 400 mg .....................................
NDA 019304 ......
NDA 019384 ......
NDA 020073 ......
Cardene SR (nicardipine HCl) Extended-Release Capsules,
30 mg, 45 mg, and 60 mg.
Romazicon (flumazenil) Injection .............................................
NDA 020084 ......
NDA 020107 ......
NDA 020229 ......
mstockstill on DSK3G9T082PROD with NOTICES
NDA 020005 ......
Iobenguane Sulfate I–131 Injection, 2.3 millicuries .................
Novamine (amino acids) Injection ............................................
Leustatin (cladribine) Injection, 1 mg/mL .................................
NDA 020251 ......
Zantac (ranitidine HCl) Effervescent Tablets, 25 mg and 150
mg Zantac (ranitidine HCl) Effervescent Granules, 150 mg.
NDA 020312 ......
NDA 020346 ......
Univasc (moexipril HCl) Tablets, 7.5 mg and 15 mg ...............
Zyrtec (cetirizine HCl) Syrup, 1 mg/mL ...................................
NDA 020410 ......
Gastromark (ferumoxsil) Oral Suspension ...............................
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Endo Pharmaceuticals, Inc., 100 Endo Blvd., Chadds Ford,
PA 19317.
Meda Pharmaceuticals, Inc.
Valeant International Bermuda, c/o Valeant Pharmaceuticals
North America, LLC, 400 Somerset Corporate Blvd.,
Bridgewater, NJ 08807.
Merck Consumer Care, 556 Morris, Ave., Summit, NJ 07901.
Organon USA Inc.
Baxter Healthcare Corp., 32650 N. Wilson Rd., Round Lake,
IL 60073.
Sandoz, Inc., 4700 Sandoz, Dr., Wilson, NC 27893.
Pharmacia & Upjohn Co., c/o Pfizer, Inc., 235 East 42nd St.,
New York, NY 10017.
Teva Pharmaceuticals USA, Inc., 1090 Horsham Rd., P.O.
Box 1090, North Wales, PA 19454.
AbbVie Inc., 1 N. Waukegan Rd., Dept. PA77/Bldg. AP30,
North Chicago, IL 60064.
Merck Sharp & Dohme Corp., 351 North Sumneytown Pike,
P.O. Box 1000, North Wales, PA 19454.
Chiesi USA, Inc., 1255 Crescent Green Dr., Suite 250, Cary,
NC 27518.
Hoffman-LaRoche, Inc., c/o Genetech, Inc., 1 DNA Way MS
#241B, South San Francisco, CA 94080–4900.
Pharmalucence, 10 DeAngelo Dr., Bedford, MA 01730.
Baxter Healthcare Corp.
Janssen Pharmaceuticals Inc., 920 Route 202 South, P.O.
Box 300, Raritan, NJ 08869–0602.
Glaxo Group Limited, England d/b/a GlaxoSmithKline, Five
Moore Dr., P.O. Box 13398, Research Triangle Park, NC
27709.
UCB, Inc.
Johnson and Johnson Consumer Inc., McNeil Consumer
Healthcare Division, 7050 Camp Hill Rd., Fort Washington,
PA 19034–2299.
AMAG Pharmaceuticals, 100 Haydon Ave., Lexington, MA
02421.
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Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices
TABLE 1—Continued
Application No.
Drug
Applicant
NDA 020416 ......
NDA 020460 ......
Feridex I.V. (ferumoxides) Injection .........................................
Cytovene (ganciclovir) Capsules, 250 mg and 500 mg ..........
NDA 020575 ......
DentiPatch (lidocaine) ..............................................................
NDA 020638 ......
Vistide (cidofovir) Injection, Equivalent to (EQ) 75 mg base/
mL.
Uniretic (moexipril HCl and hydrochlorothiazide) Tablets, 7.5
mg/12.5 mg, 15 mg/12.5 mg, and 15 mg/25 mg.
Palladone (hydromorphone HCl) Extended-Release Capsules
Do.
Roche Palo Alto LLC, c/o Genentech, Inc., 1 DNA Way,
MS#241B, South San Francisco, CA 94080–4990.
Noven Pharmaceuticals, Inc., 11960 SW. 144th St., Miami,
FL 33186.
Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA
94404.
UCB, Inc.
NDA 020729 ......
NDA 021044 ......
NDA 021046 ......
NDA 021378 ......
NDA 021671 ......
Celexa (citalopram hydrobromide) EQ 10 mg base/5 mL Oral
Solution.
Combunox (Oxycodone HCl and Ibuprofen) Tablets ..............
DepoDur (morphine sulfate) Extended-Release Injection .......
NDA 021693 ......
Rybix ODT (tramadol HCl) Orally Disintegrating Tablets ........
NDA 021768 ......
Fludeoxyglucose F18 (FDG) Injection .....................................
NDA 022244 ......
NDA 022312 ......
Lusedra (fospropofol disodium) Injection .................................
Docetaxel Injection ...................................................................
ANDA 040223 ....
Acetaminophen and Codeine Phosphate Tablets USP, 300
mg/15 mg, 300 mg/30 mg, and 300 mg/60 mg.
Estradiol Tablets USP, 0.5 mg, 1 mg, and 2 mg ....................
ANDA 040297 ....
ANDA 040311 ....
....
....
....
....
Medroxyprogesterone Acetate Tablets USP, 2.5 mg, 5 mg,
and 10 mg.
Meperidine HCl Tablets USP, 50 mg and 100 mg ..................
Dextroamphetamine Saccharate, Amphetamine Aspartate,
Dextroamphetamine Sulfate, and Amphetamine Sulfate
Tablets.
Chloromycetin (chloramphenicol ophthalmic solution USP)
Ophthalmic Solution.
Chloromycetin (chloramphenicol ophthalmic ointment USP)
Ophthalmic Ointment, 1%.
Blenoxane (bleomycin sulfate) for Injection, EQ 15 units
base/vial and 30 units base/vial.
Primaxin (imipenem and cilastatin sodium) Powder, EQ 500
mg base/vial; 500 mg/vial and EQ 750 mg base/vial; 750
mg/vial.
Penicillin G Potassium Tablets USP ........................................
Penicillin G Potassium for Oral Solution USP .........................
Cephalexin Capsules USP, EQ 250 mg base and EQ 500
mg base.
Cloxacillin Sodium Capsules USP, EQ 250 mg base and EQ
500 mg base.
Oxacillin Sodium for Oral Solution USP, EQ 250 mg base/5
mL.
Cloxacillin Sodium for Oral Solution USP, EQ 125 mg base/5
mL.
Doryx (doxycycline hyclate) Delayed-Release Capsules, EQ
100 mg base.
Nystatin Oral Suspension USP, 100,000 units/mL ..................
Cephradine Capsules USP, 250 mg and 500 mg ...................
Cefadroxil Capsules USP, EQ 500 mg base ...........................
Erythromycin Pledgets USP, 2% .............................................
ANDA 062760 ....
ANDA 062761 ....
ANDA 062766 ....
Cephalexin Capsules USP, EQ 250 mg base .........................
Cephalexin Capsules USP, EQ 500 mg base .........................
Cefadroxil Capsules USP, EQ 500 mg base ...........................
ANDA 062767 ....
ANDA 062768 ....
ANDA 062775 ....
Cephalexin for Oral Suspension USP, EQ 125 mg base/5 mL
Cephalexin for Oral Suspension USP, EQ 250 mg base/5 mL
Cephalexin Capsules USP, EQ 500 mg base .........................
ANDA
ANDA
ANDA
ANDA
Amoxicillin
Amoxicillin
Amoxicillin
Amoxicillin
ANDA 040318 ....
ANDA 040472 ....
NDA 050143 ......
NDA 050156 ......
NDA 050443 ......
NDA 050630 ......
ANDA 060306 ....
ANDA 060307 ....
ANDA 061969 ....
ANDA 062240 ....
ANDA 062252 ....
ANDA 062268 ....
ANDA 062653 ....
mstockstill on DSK3G9T082PROD with NOTICES
ANDA
ANDA
ANDA
ANDA
062670
062683
062695
062751
062853
062854
062946
063001
VerDate Sep<11>2014
....
....
....
....
19:01 Oct 03, 2016
Capsules USP, 250 mg .........................................
Capsules USP, 500 mg .........................................
for Oral Suspension USP, 125 mg/5 mL ...............
for Oral Suspension USP, 250 mg/5 mL ...............
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Rhodes Pharmaceuticals L.P., 498 Washington St., Coventry, RI 02816.
Forest Laboratories, Inc., Harborside Financial Center, Plaza
V, Suite 1900, Jersey, City, NJ 07311.
Do.
Pacira Pharmaceuticals, Inc., 10450 Science Center Dr., San
Diego, CA 92121.
Shionogi, Inc., 300 Campus Dr., Suite 300, Florham Park, NJ
07932.
Weill Medical College of Cornell University, c/o Citigroup Biomedical Imaging Center, 516 East 72nd St., New York, NY
10021.
Eisai, Inc., 155 Tice Blvd., Woodcliff Lake, NJ 07677.
Apotex Inc., c/o Apotex Corp., 2400 North Commerce Parkway, Suite 400, Weston, FL 33326.
Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, Inc., 425 Privet Rd., Horsham, PA 19044.
Upsher-Smith Laboratories, Inc., 6701 Evenstad Dr., Maple
Grove, MN 55369.
Duramed Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA Inc., 425 Privet Rd., Horsham, PA 19044.
Do.
Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham,
PA 19044.
Parkedale Pharmaceuticals, Inc., c/o King Pharmaceuticals,
Inc., 501 Fifth St., Bristol, TN 37620.
Do.
Bristol-Myers Squibb Co.
Merck, Sharp & Dohme Corp.
Teva Pharmaceuticals USA, Inc.
Do.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Teva Pharmaceuticals USA, Inc.
Teva Pharmaceuticals USA, Inc.
Do.
Warner Chilcott Co., LLC, c/o Warner Chilcott (US), LLC,
100 Enterprise Dr., Rockaway, NJ 07866.
Teva Pharmaceuticals USA, Inc.
Do.
Do.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Teva Pharmaceuticals USA, Inc.
Do.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Teva Pharmaceuticals USA, Inc.
Do.
Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, Inc.
Teva Pharmaceuticals USA, Inc.
Do.
Do.
Do.
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Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices
68429
TABLE 1—Continued
Application No.
Drug
ANDA 063018 ....
Cefazolin Sodium for Injection USP, EQ 5 grams (g) base/
vial and EQ 10 g base/vial.
Clindamycin HCl Capsules USP, EQ 75 mg base ..................
Amoxicillin Capsules USP, 250 mg .........................................
Amoxicillin Capsules USP, 500 mg .........................................
Amoxicillin Chewable Tablets, 125 mg and 250 mg ...............
Cefaclor Capsules USP, EQ 250 mg base and EQ 500 mg
base.
Cefaclor Capsules USP, EQ 250 mg base and EQ 500 mg
base.
Clarithromycin Tablets USP, 250 mg and 500 mg ..................
ANDA
ANDA
ANDA
ANDA
ANDA
063027
063030
063031
064031
064081
....
....
....
....
....
ANDA 064145 ....
ANDA 065137 ....
ANDA 070006 ....
ANDA 070007 ....
ANDA
ANDA
ANDA
ANDA
ANDA
070232
070234
070266
070267
070469
....
....
....
....
....
ANDA 070618 ....
Applicant
Sulfamethoxazole and Trimethoprim Tablets USP, 400 mg/80
mg.
Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/
160 mg.
Propranolol HCl Tablets USP, 10 mg ......................................
Propranolol HCl Tablets USP, 40 mg ......................................
Indo-Lemmon (Indomethacin Capsules USP), 25 mg .............
Indo-Lemmon (Indomethacin Capsules USP), 50 mg .............
Ibuprohn (Ibuprofen Tablets USP), 400 mg ............................
ANDA 070660 ....
ANDA 071145 ....
Potassium Chloride Extended-Release Tablets USP, 8 milliequivalents.
Metoclopramide HCl Tablets USP, EQ 10 mg base ...............
Ibuprofen Tablets USP .............................................................
ANDA
ANDA
ANDA
ANDA
ANDA
....
....
....
....
....
Ibuprofen Tablets USP, 600 mg ..............................................
Thiothixene HCl Oral Solution USP, EQ 5 mg base/mL .........
Indomethacin Capsules USP, 25 mg .......................................
Indomethacin Capsules USP, 50 mg .......................................
Fenoprofen Calcium Capsules USP, EQ 300 mg base ..........
ANDA 072522 ....
ANDA 072600 ....
ANDA 072692 ....
ANDA 072999 ....
Fluocinonide Topical Solution USP, 0.05% .............................
Clofibrate Capsules USP, 500 mg ...........................................
Norethindrone and Ethinyl Estradiol Tablets USP, 0.5 mg/
0.035 mg.
Dopamine HCl Injection USP, 200 mg/5 mL ...........................
ANDA
ANDA
ANDA
ANDA
ANDA
073005
073006
073043
073044
073099
....
....
....
....
....
Cinoxacin Capsules USP, 250 mg ..........................................
Cinoxacin Capsules USP, 500 mg ..........................................
Baclofen Tablets USP, 10 mg .................................................
Baclofen Tablets USP, 20 mg .................................................
Leucovorin Calcium Tablets USP, EQ 5 mg base ..................
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
073101
073141
073315
073316
073343
073344
073345
073515
073679
074067
....
....
....
....
....
....
....
....
....
....
Leucovorin Calcium Tablets USP, EQ 25 mg base ................
Ibuprofen Tablets USP, 200 mg ..............................................
Atenolol Tablets USP, 50 mg ..................................................
Atenolol Tablets USP, 100 mg ................................................
Ibuprofen Tablets USP, 400 mg ..............................................
Ibuprofen Tablets USP, 600 mg ..............................................
Ibuprofen Tablets USP, 800 mg ..............................................
Ketoprofen Capsules USP, 25 mg ...........................................
Diflunisal Tablets USP, 250 mg ...............................................
Diltiazem HCl Tablets USP, 30 mg, 60 mg, 90 mg, and 120
mg.
Atenolol and Chlorthalidone Tablets USP, 50 mg/25 mg and
100 mg/25 mg.
Atenolol Tablets USP, 50 mg and 100 mg ..............................
Pindolol Tablets USP, 5 mg and 10 mg ..................................
071146
071184
071342
071343
072438
ANDA 074107 ....
ANDA 074120 ....
ANDA 074123 ....
mstockstill on DSK3G9T082PROD with NOTICES
ANDA 074124 ....
ANDA 074143 ....
ANDA 074216 ....
ANDA 074294 ....
ANDA 074333 ....
ANDA 074357 ....
ANDA 074365 ....
VerDate Sep<11>2014
Ciprofloxacin HCl Tablets, EQ 250 mg base, EQ 500 mg
base, and EQ 750 mg base.
Metoprolol Tartrate Tablets USP, 50 mg and 100 mg ............
Naproxen Tablets, 250 mg, 375 mg, and 500 mg ..................
Alprazolam Tablets USP, 0.25 mg, 0.5 mg, 1 mg, and 2 mg
Metoprolol Tartrate Tablets USP, 50 mg and 100 mg ............
Trazodone HCl Tablets USP, 150 mg .....................................
Cimetidine Tablets USP, 200 mg, 300 mg, 400 mg, and 800
mg.
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Do.
Do.
Do.
Do.
Do.
Do.
Do.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Mutual Pharmaceutical Co., Inc., 1100 Orthodox St., Philadelphia, PA 19124.
Do.
Teva Pharmaceuticals USA, Inc.
Do.
Do.
Do.
Ohm Laboratories, Inc., c/o Ranbaxy Inc., 600 College Rd.
East, Princeton, NJ 08540.
Copley Pharmaceutical, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
Mutual Pharmaceutical Co., Inc.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Do.
Teva Pharmaceuticals USA, Inc.
Do.
Do.
Par Pharmaceutical, Inc., One Ram Ridge Rd., Spring Valley, NY 10977.
Teva Pharmaceuticals USA, Inc.
Do.
Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals,
USA, Inc.
Teva Parenteral Medicines, Inc., 425 Privet Rd., Horsham,
PA 19044.
Teva Pharmaceuticals USA, Inc.
Do.
Do.
Do.
Pharmachemie B.V., Subsidiary of Teva Pharmaceuticals
USA, Inc., 425 Privet Rd., Horsham, PA 19044.
Do.
Teva Pharmaceuticals USA, Inc.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.,
425 Privet Rd., Horsham, PA 19044.
Teva Pharmaceuticals USA, Inc.
G&W Laboratories, Inc., 111 Coolidge St., South Plainfield,
NJ 07080.
Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, Inc.
Teva Pharmaceuticals USA, Inc.
Do.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Teva Pharmaceuticals USA, Inc.
Do.
Do.
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Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices
TABLE 1—Continued
Application No.
Drug
ANDA 074446 ....
Terazosin HCl Tablets, EQ 1 mg base, EQ 2 mg base, EQ 5
mg base, and EQ 10 mg base.
Diclofenac Sodium Delayed-Release Tablets USP, 25 mg, 50
mg, and 75 mg.
Hydroxyurea Capsules USP, 500 mg ......................................
ANDA 074459 ....
ANDA 074476 ....
ANDA 074504 ....
Applicant
ANDA 074537 ....
ANDA 074555 ....
ANDA 074674 ....
Tamoxifen Citrate Tablets USP, EQ 10 mg base and EQ 20
mg base.
Selegiline HCl Tablets USP, 5 mg ...........................................
Cholestyramine for Oral Suspension USP ..............................
Acyclovir Capsules USP, 200 mg ............................................
ANDA
ANDA
ANDA
ANDA
074745
074771
074847
074883
....
....
....
....
Megestrol Acetate Tablets USP, 40 mg ..................................
Cholestyramine for Oral Suspension USP ..............................
Etodolac Tablets USP, 400 mg and 500 mg ...........................
Etodolac Tablets USP, 400 mg and 500 mg ...........................
ANDA
ANDA
ANDA
ANDA
ANDA
074895
074914
074989
075021
075557
....
....
....
....
....
Amiodarone HCl Tablets, 200 mg ...........................................
Acyclovir Capsules USP, 200 mg ............................................
Labetalol HCl Tablets USP, 100 mg, 200 mg, and 300 mg ....
Acyclovir Tablets USP, 400 mg and 800 mg ..........................
Ranitidine HCl Capsules, EQ 150 mg base and EQ 300 mg
base.
Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP,
2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg.
Sertraline HCl Tablets USP, EQ 25 mg base, EQ 50 mg
base, and EQ 100 mg base.
Pemoline Tablets, 18.75 mg, 37.5 mg, and 75 mg .................
ANDA 075686 ....
ANDA 075719 ....
ANDA 075726 ....
ANDA 075740 ....
ANDA 075810 ....
ANDA 075823 ....
ANDA 075827 ....
ANDA 075862 ....
ANDA 075865 ....
ANDA 075971 ....
ANDA 075975 ....
Tamoxifen Citrate Tablets USP, EQ 10 mg base and EQ 20
mg base.
Fluoxetine HCl Tablets , EQ 10 mg base ................................
Calcitriol Injection USP, 0.001 mg/mL and 0.002 mg/mL .......
Gabapentin Tablets USP, 600 mg and 800 mg ......................
Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.1 mg/
0.02 mg.
Fluoxetine HCl Tablets , EQ 10 mg base and EQ 40 mg
base.
Metformin HCl Tablets USP, 500 mg, 850 mg, and 1 g .........
ANDA 076244 ....
Metformin HCl Tablets USP, 500 mg, 625 mg, 750 mg, 850
mg, and 1 g.
Pergolide Mesylate Tablets, EQ 0.05 mg base, EQ 0.25 mg
base, and EQ 1 mg base.
Alendronate Sodium Tablets USP, EQ 35 mg tablets and EQ
70 mg tablets.
Balziva-21 Tablets (norethindrone and ethinyl estradiol tablets USP), 0.4 mg/0.035 mg.
Mirtazapine Tablets USP, 15 mg, 30 mg, and 45 mg .............
ANDA 076251 ....
Fluoxetine HCl Capsules, EQ 40 mg base ..............................
ANDA 076328 ....
ANDA 076340 ....
Metformin HCl Tablets USP, 500 mg, 850 mg, and 1 g .........
Finasteride Tablets USP, 5 mg ................................................
ANDA 076426 ....
ANDA 076496 ....
Ciprofloxacin HCl Tablets , EQ 100 mg base, EQ 250 mg
base, EQ 500 mg base, and EQ 750 mg base.
Metformin HCl Extended-Release Tablets USP, 500 mg .......
ANDA 076545 ....
Metformin HCl Extended-Release Tablets USP, 500 mg .......
ANDA 076840 ....
Sumatriptan Succinate Tablets, EQ 25 mg base, EQ 50 mg
base, and EQ 100 mg base.
Nicotine Polacrilex Gum USP, EQ 2 mg base ........................
ANDA 076094 ....
ANDA 076184 ....
mstockstill on DSK3G9T082PROD with NOTICES
ANDA 076198 ....
ANDA 076880 ....
ANDA 076945 ....
ANDA 077020 ....
ANDA 077082 ....
VerDate Sep<11>2014
Fosinopril Sodium and Hydrochlorothiazide Tablets USP, 10
mg/12.5 mg and 20 mg/12.5 mg.
Cilostazol Tablets USP, 100 mg ..............................................
Paroxetine Tablets USP, EQ 10 mg base, EQ 20 mg base,
EQ 30 mg base, and EQ 40 mg base.
19:01 Oct 03, 2016
Jkt 241001
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Frm 00033
Fmt 4703
Sfmt 4703
Do.
Do.
Roxane Laboratories, Inc., 1809 Wilson Rd., Columbus, OH
43228.
Teva Pharmaceuticals USA, Inc.
G&W Laboratories, Inc.
Teva Pharmaceuticals, USA, Inc.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Teva Pharmaceuticals USA, Inc.
Do.
Do.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Teva Pharmaceuticals USA, Inc.
Do.
Do.
Do.
Do.
Do.
Do.
Mallinckrodt Inc., 675 McConnell Blvd., Hazelwood, MO
63042.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, Inc.
Teva Parenteral Medicines, Inc.
Teva Pharmaceuticals USA, Inc.
Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, Inc.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, Inc.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Do.
Teva Pharmaceuticals USA, Inc.
Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, Inc.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, Inc.
Teva Pharmaceuticals USA, Inc.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Barr Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Teva Pharmaceuticals USA, Inc.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Teva Pharmaceuticals USA, Inc.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Teva Pharmaceuticals USA, Inc.
E:\FR\FM\04OCN1.SGM
04OCN1
Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices
68431
TABLE 1—Continued
Application No.
Drug
ANDA 077775 ....
ANDA 077850 ....
Fentanyl Extended-Release Film, 25 micrograms (mcg), 50
mcg, 75 mcg, and 100 mcg.
Nicotine Polacrilex Gum USP, EQ 4 mg base ........................
ANDA 077898 ....
Cilostazol Tablets USP, 50 mg and 100 mg ...........................
ANDA 077973 ....
Bicalutamide Tablets USP, 50 mg ...........................................
ANDA 077995 ....
Bicalutamide Tablets UPS, 50 mg ...........................................
ANDA 078079 ....
ANDA 078221 ....
Ciclopirox Topical Solution USP, 8% .......................................
Granisetron HCl Tablets USP, EQ 1 mg base ........................
ANDA 078263 ....
Perindopril Erbumine Tablets, 2 mg, 4 mg, and 8 mg ............
ANDA 078567 ....
Ciclopirox Topical Solution USP, 8% .......................................
ANDA 078666 ....
Levonorgestrel Tablets, 0.75 mg .............................................
ANDA 078773 ....
ANDA 080400 ....
ANDA 080828 ....
Atorvastatin Calcium Tablets, EQ 10 mg base, EQ 20 mg
(base), EQ 40 mg base, and EQ 80 mg base.
Hydrocortisone Cream USP .....................................................
Hydrocortisone Acetate Ophthalmic Ointment USP, 0.5% ......
ANDA 083919 ....
Meprobamate Tablets USP, 600 mg .......................................
ANDA 085022 ....
Hydrochlorothiazide Tablets USP, 100 mg ..............................
ANDA 085855 ....
ANDA 087264 ....
ANDA 087665 ....
A-Methapred (methylprednisolone sodium succinate for Injection USP), EQ 125 mg base/vial.
Ergotamine Tartrate Sublingual Tablets USP, 2 mg ...............
Orgatrax (hydroxyzine HCl Injection USP), 25 mg/mL and 50
mg/mL.
Thioridazine HCl Tablets USP, 25 mg .....................................
Sulfinpyrazone Tablets USP, 100 mg ......................................
ANDA 087666 ....
ANDA 087760 ....
Sulfinpyrazone Capsules USP, 200 mg ..................................
Hydroxyzine Pamoate Capsules USP, EQ 50 mg HCl ...........
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA 088900 ....
Hydroxyzine Pamoate Capsules USP, EQ 25 mg HCl ...........
Thioridazine HCl Tablets USP, 50 mg .....................................
Thioridazine HCl Tablets USP, 10 mg .....................................
Thioridazine HCl Tablets USP, 100 mg ...................................
Dexamethasone Sodium Phosphate Injection USP, EQ 10
mg Phosphate/mL.
Doxylamine Succinate Tablets USP, 25 mg ............................
ANDA 088902 ....
Chlorthalidone Tablets USP, 25 mg ........................................
ANDA
ANDA
ANDA
ANDA
....
....
....
....
Chlorthalidone Tablets USP, 50 mg ........................................
Procainamide HCl Extended-Release Tablets USP, 500 mg
Promethazine HCl Tablets USP, 25 mg ..................................
Melphalan HCl for Injection, EQ 50 mg base/vial ...................
ANDA 090924 ....
ANDA 091242 ....
Ibutilide Fumarate Injection, 0.1 mg/mL ..................................
Anastrozole Tablets USP, 1 mg ..............................................
ANDA 091638 ....
ANDA 200792 ....
Letrozole Tablets USP, 2.5 mg ................................................
Oxymorphone HCl Extended-Release Tablets, 5 mg, 7.5 mg,
10 mg, 15 mg, 20 mg, 30 mg, and 40 mg.
Zidovudine Injection USP, 10 mg/mL ......................................
ANDA 086750 ....
ANDA 087014 ....
087761
088370
088375
088379
088469
088903
088974
089109
090299
....
....
....
....
....
mstockstill on DSK3G9T082PROD with NOTICES
ANDA 204538 ....
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
VerDate Sep<11>2014
19:01 Oct 03, 2016
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Applicant
Noven, Pharmaceuticals, Inc.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Pliva Hrvatska DOO, c/o Teva Pharmaceuticals USA,
Inc.,425 Privet Rd., Horsham, PA 19044.
Synthon Pharmaceuticals, Inc., 9000 Development Dr., P.O.
Box 110487, Research Triangle Park, NC 27709.
Kudco Ireland Limited, c/o Kremers Urban Pharmaceuticals,
Inc., 1101 C Ave. West, Seymour, IN 47274.
Teva Pharmaceuticals USA, Inc.
Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, Inc.
Lupin Limited, c/o Lupin Pharmaceuticals, Inc., 111 South
Calvert St., Harborplace Tower, 21st Floor, Baltimore, MD
21202.
Mylan Pharmaceuticals Inc., 781 Chestnut Ridge Rd., P.O.
Box 4310, Morgantown, WV 26504.
Watson Laboratories, Inc., 311 Bonnie Circle, Corona, CA
92880.
Teva Pharmaceuticals USA, Inc.
Do.
Fera Pharmaceuticals LLC, 134 Birch Hill Rd., Locust Valley,
NY 11560.
Meda Pharmaceuticals Inc., 265 Davidson Ave., Suite 400,
Somerset, NJ 08873.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Hospira, Inc.
Organon USA, Inc.
Do.
Mutual Pharmaceutical Co., Inc.
Barr Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Do.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Do.
Mutual Pharmaceutical Co., Inc.
Do.
Do.
Fresenius Kabi USA, LLC.
Copley Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, Inc.
Do.
ANI Pharmaceuticals, Inc.,.
Teva Pharmaceuticals USA, Inc.
Mylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL
61103.
Do.
Impax Laboratories, Inc., 30831 Huntwood Ave., Hayward,
CA 94544.
Do.
Par Pharmaceutical, Inc.
Liaoning Chengda Biotechnology Co., Ltd., c/o Ruby
Pharma, Inc., 116 Village Blvd, Suite 200, Princeton, NJ
08540.
Director, Center for Drug Evaluation and
Research, by the Commissioner,
approval of the applications listed in
table 1 in this document, and all
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Sfmt 4703
amendments and supplements thereto,
is hereby withdrawn, effective
November 3, 2016. Introduction or
delivery for introduction into interstate
E:\FR\FM\04OCN1.SGM
04OCN1
68432
Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–2880]
Microbiology Devices Panel of the
Medical Devices Advisory Committee;
Notice of Meeting; Establishment of a
Public Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Microbiology Devices
Panel of the Medical Devices Advisory
Committee. The general function of the
committee is to provide advice and
recommendations to the Agency on
FDA’s regulatory issues. The meeting
will be open to the public. FDA is
establishing a docket for public
comment on this document.
SUMMARY:
The meeting will be held on
November 9 and 10, 2016, from 8 a.m.
to 6 p.m.
DATES:
Gaithersburg Holiday Inn
Ballroom, 2 Montgomery Village Ave.,
Gaithersburg, MD 20879. The hotel’s
telephone number is 301–948–8900.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
You may submit comments as
follows:
mstockstill on DSK3G9T082PROD with NOTICES
ADDRESSES:
VerDate Sep<11>2014
19:01 Oct 03, 2016
Jkt 241001
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–N–2880 for ‘‘Microbiology Devices
Panel of the Medical Devices Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
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Fmt 4703
Sfmt 4703
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Aden Asefa, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993,
aden.asefa@fda.hhs.gov, 301–796–0400,
or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area). A notice in the Federal Register
about last minute modifications that
impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the Agency’s Web
site at https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: On November 9, 2016,
during session one, the committee will
E:\FR\FM\04OCN1.SGM
04OCN1
]]>Agencies
[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
