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New! As of May 1, 2004, New and Generic Drug Approvals 1998-2004,
will not be updated. |
| Product Name | Company | Application # |
Approval
Date |
Letter
|
Label
Posted |
Review
Posted |
|---|---|---|---|---|---|---|
| Ocufen Ophthalmic Solution, (0.03%) | Allergan | NDA 19-404/S020 | 8/25/03 | 8/28/03 | 8/28/03 | |
| Ocufen Ophthalmic Solution (0.03%) | Allergan | NDA 19-404/S017 | 8/17/01 | 4/15/03 | ||
| Ocufen Ophthalmic Solution (0.03%) | Allergan | NDA 19-404/S014 | 7/30/01 | 4/15/03 | ||
| Ofloxacin Injection, 40 mg/mL packaged in 10 mL single dose vials, Rx | Bedford Laboratories | ANDA 75-762 | 1/16/02 | |||
| Ofloxacin Injection, 40 mg/mL packaged in 10 mL single dose vials, Rx , Tentatively Approved | Bedford Laboratories | ANDA 75-762 | 5/23/01 | 6/5/01 | ||
| Ofloxacin Ophthalmic Solution USP, 0.3%, Rx Tentatively Approved | Hi-Tech Pharmacal | ANDA 76-615 | 4/19/04 | |||
| Ofloxacin Ophthalmic Solution USP, 0.3%, Rx Tentatively Approved | Bausch & Lomb | ANDA 76-622 | 1/23/04 | |||
| Ofloxacin Ophthalmic Solution USP, 0.3%, Rx Tentatively Approved | Novex Pharma | ANDA 76-513 | 10/22/03 | |||
| Ofloxacin Ophthalmic Solution USP, 0.3%, Rx Tentatively Approved | Alcon Universal, Ltd. | ANDA 76-231 | 5/13/02 | |||
| Ofloxacin Tablets, 200, 300 & 400 mg, Rx | Ranbaxy | ANDA 76-220 | 9/2/03 | |||
| Ofloxacin Tablets, 200, 300 & 400 mg, Rx | Teva Pharmaceuticals | ANDA 76-182 | 9/2/03 | |||
| Ofloxacin Tablets, 200, 300 & 400 mg, Rx Tentatively Approved | Teva Pharmaceuticals | ANDA 76-182 | 11/23/01 | 4/16/03 | ||
| Ofloxacin Tablets, 200, 300 & 400 mg, Rx | Ofloxacin Tablets, Par Pharmaceutical | ANDA 76-093 | 9/2/03 | |||
| Ofloxacin Tablets, 200, 300 & 400 mg, Rx Tentatively Approved | Par Pharmaceutical, Inc. | ANDA 76-093 | 12/5/01 | 4/16/03 | ||
| Ogestrel 0.5/50-21 and Ogestrel 0.5/50-28 Tablets (Norgestrel and Ethinyl Estradiol Tablets USP, 0.5 mg and 0.05 mg, respectively) | SCS Pharmaceuticals | ANDA 75-406 | 12/15/99 | |||
| Olux (clobetasol propionate) Foam, 0.05%, Rx | Connetics Corporation | NDA 21-142/S10 | 12/29/03 | 1/2/03 | 1/2/03 | |
| Olux (clobetasol propionate) Foam, 0.05%, Rx | Connetics Corporation | NDA 21-142/S9 | 10/31/03 | 11/25/03 | 12/2/03 | |
| Olux (clobetasol propionate) Foam, 0.05%, Rx | Connetics Corporation | NDA 21-142/S7 | 7/21/03 | 7/28/03 | ||
| Olux (clobetasol propionate) Foam, 0.05%, Rx | Connetics Corporation | NDA 21-142/S4 | 12/20/02 | 1/29/03 | 4/7/03 | |
| Olux (clobetasol propionate) Foam, 0.05%, Rx | Connetics Corporation | NDA 21-142/S3 | 3/13/02 | 3/29/02 | ||
| Olux (clobetasol propionate) Foam, 0.05%, Rx | Connetics Corporation | NDA 21-142 | 5/26/00 | 6/6/00 | 6/6/00 | 3/28/04 |
| Omeprazole Capsules, 10 mg & 20 mg, Rx Tentatively Approved | Genpharm Inc. | ANDA 75-268 | 10/18/02 | |||
| Omeprazole delayed-release Capsules, 10 mg 20 & (40 mg Tentatively Approved), Rx | Torpharm | ANDA 76-048 | 10/6/03 | |||
| Omeprazole delayed-release Capsules, 10 mg 20 & (40 mg Tentatively Approved), Rx | Mylan Pharmaceuticals Inc. | ANDA 75-876 | 5/29/03 | |||
| Omeprazole delayed-release Capsules, 10 mg & 20 mg, Rx | Eon Labs, Inc. | ANDA 75-791 | 10/24/02 | |||
| Omeprazole delayed-release Capsules, 10 mg & 20 mg, Rx Tentatively Approved | Eon Labs, Inc. | ANDA 75-791 | 10/24/02 | |||
| Omeprazole delayed-release Capsules, 10 & 20 mg, Rx (40 mg dosage Tentatively Approved) | IMPAX Laboratories, Inc. | ANDA 75-785 | 11/8/02 | |||
| Omeprazole delayed-release Capsules, 10 mg & 20 mg, Rx | Lek Pharmaceuticals | ANDA 75-757 | 1/28/03 | |||
| Omeprazole delayed-release Capsules, 10 mg & 20 mg, Rx | Kremers Urban Development Co. | ANDA 75-410 | 11/1/02 | |||
| Omeprazole delayed-release Capsules, 10 mg & 20 mg, Rx Tentatively Approved | Kremers Urban Development Co. | ANDA 75-410 | 5/3/01 | 6/5/01 | ||
| Omeprazole delayed-release Capsules, 10 mg, 20 mg, & 40 mg, Rx | Andrx Pharmaceuticals, Inc. | ANDA 75-347 | 11/16/01 | 12/18/01 | ||
| Omeprazole delayed-release Capsules, 10 mg, 20 mg, & 40 mg, Rx Tentatively Approved 3/23/00 | Andrx Pharmaceuticals, Inc. | ANDA 75-347 | 3/23/00 | 3/31/00 | ||
| Omnicef (cefdinir) Capsules, | Abbott Laboratories | NDA 50-739/S-006 | 7/24/02 | 8/6/02 | ||
| Omnicef (cefdinir) Capsules, | Parke-Davis | NDA 50-739/S-002 | 11/24/99 | 12/30/99 | 12/30/99 | |
| Omnicef (cefdinir) Powder Oral Suspension | Parke-Davis | NDA 50-749/SE2-002 | 7/14/99 | 7/29/99 | 7/29/99 | |
| Omnicef Indication: 5-day dosing regimen (7 mg/kg BID) for the treatment of AOM | ||||||
| Omnipaque (iohexol) Injection, | Amersham Health | NDA 20-608/S10 | 2/10/04 | 3/3/04 | ||
| Omnipaque (iohexol) Injection, | Amersham Health | NDA 20-608/S9 | 3/5/04 | 3/10/04 | ||
| Omnipaque (iohexol) Injection, | Amersham Health | NDA 18-956/S58 | 3/5/04 | 3/10/04 | ||
| Omnipaque (iohexol) Injection, | Amersham Health | NDA 18-956/SLR-049 | 12/23/02 | 1/29/03 | ||
| Omnipaque (iohexol) Injection, | Amersham Health | NDA 18-956/SLR-039 | 12/23/02 | 1/29/03 | ||
| Omniscan (Gadodiamide) Injection, | Amersham Health | NDA 20-123/S-023 | 11/15/02 | 7/31/03 | ||
| Omniscan, | Amersham Health | NDA 20-123/S-022 | 6/28/02 | 7/2/02 | ||
| Omniscan Injection, | Amersham Health | NDA 20-123/S-021 | 5/17/02 | 5/23/02 | ||
| OMNISCAN (gadodiamide) Injection, | Nycomed Amersham Imaging | NDA 20-123/S-018 | 7/8/02 | 7/9/02 | ||
| Ondansetron Injection, 2mg/mL, Rx Tentatively Approved | Mayne Pharma Inc. | ANDA 76-696 | 2/26/04 | |||
| Ondansetron Injection, 2mg/mL, Rx Tentatively Approved | Mayne Pharma Inc. | ANDA 76-695 | 2/26/04 | |||
| Ophthetic (proparacaine HCl ophthalmic solution), 0.5%, | Allergan, Inc. | NDA 12-583/S-028 & 12-583/S-037 | 6/20/02 | 6/24/02 | 6/21/02 | |
| OptiMark (gadoversetamide) Injection, | Tyco/Mallinckrodt Health Care | NDA 20-937/S3 NDA 20-975/S3 NDA 20-976/S3 |
1/31/03 | 2/12/03 | 2/13/03 | 1/29/04 |
| OptiMark (gadoversetamide) Injection | Mallinckrodt, Inc. | NDA 20-937 NDA 20-975 NDA 20-976 |
12/8/99 | 1/21/00 | 5/31/01 | |
| OPTIMINE (azatadine maleate USP) Tablets. | Schering Corporation | NDA 17-601/SLR-020 | 11/4/02 | 11/19/02 | ||
| Optiray (ioversol injection), 74%, 68%, 51% | Mallinckrodt Medical, Inc. | NDA 20-923 | 5/28/98 | 5/29/98 | 5/29/98 | 3/9/04 |
| Optison (Human Albumin Microspheres) Injectable Suspension Octofluoropropane Formulation, | Mallinckrodt Inc. | NDA 20-899/SCM-007 | 5/10/02 | 5/29/02 | ||
| OPTIVAR (azelastine hydrochloride ophthalmic solution), 0.05%, Rx | ASTA Medica, Inc. | NDA 21-127 | 5/22/00 | 5/23/00 | 5/23/00 | 2/15/02 |
| Optivar Indications: Treatment of itching of the eye, associated with allergic conjunctivitis. | ||||||
| Oramorph (morphine sulfate) Sustained Release Tablets | Roxane Laboratories, Inc. | NDA 19-977/S-004, S-007 | 7/13/01 | 2/14/02 | ||
| Orap (pimozide) Tablets, | Teva Pharmaceuticals | NDA 17-473/SLR-039 | 10/27/03 | 11/5/03 | ||
| Orap (pimozide) Tablets, | Teva Pharmaceuticals | NDA 17-473/SLR-038 | 11/14/02 | 11/22/02 | ||
| Orapred (Prednisolone Sodium Phosphate) Oral Solution, 15 mg (base)/5 mL, Rx | Ascent Pediatrics | ANDA 75-117 | 12/14/00 | 2/28/01 | 1/3/02 | |
| Oraqix (Lidocaine & Prilocaine) Periodontal Gel, 2.5%/2.5%, Rx | Dentsply Pharmaceutical | NDA 21-451 | 12/19/03 | 12/23/03 | 12/29/03 | |
| Orfadin (Nitisinone) Capsules, Rx | Swedish Orphan, AB (R&R Registration is the U.S. Agent | NDA 21-232 | 1/18/02 | 2/5/02 | 2/5/02 | 2/28/02 |
| Orfadin Indications: An adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia tyep 1. | ||||||
| Orgaran (Danaparoid Sodium) Injection, 0.6 mL, Rx | Organon Inc. | NDA 20-430/S003 | 7/13/01 | 11/6/01 | 12/11/01 | |
| Orlaam (levomethadyl acetate HCl). | Roxane Laboratories | NDA 20-315/S-006 | 3/30/01 | 5/1/01 | ||
| Orphenadrine Citrate Injection, 30 mg/mL, Rx | Bedford Laboratories | ANDA 40-463 | 3/4/03 | |||
| Orphenadrine Citrate Extended-Release Tablets, 100 mg, Rx | Impax Laboratories, Inc. | ANDA 40-368 | 6/23/00 | 10/30/00 | ||
|
Orphenadrine Citrate Extended-Release
Tablets, 100 mg, Rx Approved 1/29/1999 |
Kiel Laboratories, Inc. | ANDA# 40-249 | 1/29/99 | 2/5/99 | 8/1/03 | |
| Orphenadrine Citrate Extended-release Tablets, 100 mg, Rx | Invamed Inc. |
ANDA 40-284 | 6/19/98 | 6/19/98 | ||
| Orphenadrine Citrate Extended-release Tablets, 100 mg. | Eon Labs Manufacturing, Inc. | ANDA 40-327 | 2/15/00 | 2/17/00 | ||
| Orphenadrine Citrate, Aspirin, & Caffeine Tablets,25 mg/385 mg, & 50 mg/770 mg/60 mg. | Jerome Stevens Pharmaceuticals, Inc. | ANDA 74-988 | 4/30/99 | 5/4/99 | ||
| Orphengesic(Orphenadrine Citrate 25 mg, Aspirin 385 mg & Caffeine 30 mg) & Orphengesic Forte(Orphenadrine Citrate 50 mg, Aspirin 770 mg & Caffeine 60 mg). | Par Pharmaceuticals, Inc. | ANDA 75-141 | 5/29/98 | 3/22/99 | ||
| ORTHO EVRA (Norelgestromin/Ethinyl Estradiol) Transdermal System, 600 mg/0.75 mg, Rx | Ortho-McNeil Pharmaceutical, Inc. | NDA 21-180/S8 | 2/4/04 | 3/3/04 | ||
| ORTHO EVRA (Norelgestromin/Ethinyl Estradiol) Transdermal System, 600 mg/0.75 mg, Rx | R.W. Johnson Pharmaceutical Research Institue | NDA 21-180 | 11/20/01 | 2/12/02 | 2/12/02 | 2/12/02 |
| Ortho Micronor (Norethindrone) Tablets, Rx | Johnson & Johnson | NDA 16-954/S92 | 10/1/03 | 10/1/03 | 10/9/03 | |
| Ortho-Prefest (estradiol/norgestimate) Tablets, Rx | King Pharmaceuticals | NDA 21-040/S10 | 1/23/03 | 1/27/03 | ||
| Ortho-Prefest (17b-estradiol and 17b-estradiol/norgestimate), tablets [Patient Information] | R.W. Johsnons | NDA 21-040 | 10/22/99 | 12/30/99 | 12/30/99 | |
| ORTHO TRI-CYCLEN Lo (norgestimate/ethinyl estradiol) Tablets, Rx | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | NDA 21-241 | 8/22/02 | 8/26/02 | 8/23/02 | |
| Orudis (Ketoprofen) Capsules and Extended-release Capsules, | Wyeth Pharmaceuticals | NDA 18-754/S26 | 8/18/03 | 8/26/03 | ||
| Ovcon 35 (norethindrone and ethinyl estradiol) tablets, chewable, | Warner Chilcott, Inc. | NDA 21-490 | 11/14/03 | 11/28/03 | ||
| Ovide (Malathion) Lotion, 5% | Medicis Pharmaceutical Corporation | NDA 18-613/S011 | 4/4/03 | 4/16/03 | 4/16/03 | |
| Ovide (Malathion) Lotion, 5% | Medicis Pharmaceutical Corporation | NDA 18-613/S009 & 010 | 4/30/99 | 6/22/01 | ||
| Ovral (norgestrel and ethinyl estradiol), Ovral-28 (norgestrel and ethinyl estradiol). | Wyeth-Ayerst Laboratories | NDA 16-672/S-046 & 16-806/S-028 | 3/23/01 | 5/1/01 | ||
| Ovidrel (choriogonadotropin alfa) Injection, Rx | Serono, Inc. | NDA 21-149/S6 | 7/14/03 | 7/28/03 | ||
| Ovidrel (choriogonadotropin alfa) Injection, Rx | Serono Laboratories, Inc. | NDA 21-149 | 9/20/00 | 9/21/00 | 9/21/00 | |
| Oxacillin Injection, USP, in Galaxy Plastic Container | Baxter Healthcare Corporation | NDA 50-640/S7 | 3/17/04 | 3/23/04 | ||
| Oxacillin Injection, USP, in Galaxy Plastic Container | Baxter Healthcare Corporation | NDA 50-640/S-006 | 8/23/02 | 8/30/02 | ||
| Oxandrin (oxandrolone) Tablets, Rx | Bio-Technology General Corporation | NDA 13-718/S-022 | 4/21/03 | |||
| Oxandrin (oxandrolone) Tablets | Bio-Technology General Corporation | NDA 13-718/S-020 & S-021 | 11/5/01 | 11/21/02 | 6/10/03 | |
| Oxaprozin Tablets, 600 mg, Rx | Dr. Reddy's Laboratories Limited | ANDA 75-855 | 1/31/01 | 3/5/01 | ||
| Oxaprozin Tablets, 600 mg, Rx | Mylan Pharmaceuticals, Inc. | ANDA 75-851 | 8/17/01 | 4// | 12/24/03 | |
| Oxaprozin Tablets, 600 mg, Rx | Watson Laboratories, Inc. | ANDA 75-848 | 2/9/01 | 3/6/01 | ||
| Oxaprozin Tablets, 600 mg, Rx | Genpharm Inc. | ANDA 75-847 | 2/28/01 | 3/6/01 | ||
| Oxaprozin Tablets, 600 mg, Rx | Eon labs manufacturing, Inc. | ANDA 75-845 | 1/31/01 | 3/5/01 | ||
| Oxybutynin Chloride Syrup USP, 5 mg/5 mL. | Pharmaceutical Associates, Inc. | ANDA 75-137 | 12/18/98 | 12/18/98 | ||
| Oxybutynin Chloride Syrup USP, 5mg/mL, Rx | Mikart, Inc. | ANDA 75-039 | 1/29/99 | |||
| Oxaprozin Tablets, 600 mg, Rx | Mylan Pharmaceuticals, Inc. | ANDA 75-851 | 8/17/01 | 4/15/03 | 12/5/01 | |
| Oxaprozin Tablets, 600 mg, Rx | Geneva Pharmaceuticals, Inc. | ANDA 75-850 | 4/27/01 | 6/5/01 | ||
| Oxaprozin Tablets, 600 mg, Rx | Teva Pharmaceuticals | ANDA 75-849 | 7/3/02 | |||
| Oxaprozin Tablets, 600 mg, Rx | Watson Laboratories, Inc. | ANDA 75-848 | 2/9/01 | |||
| Oxaprozin Tablets, 600 mg, Rx | IVAX Pharmaceuticals | ANDA 75-846 | 5/13/02 | |||
| Oxaprozin Tablets, 600 mg, Rx | Caraco Pharmaceutical Laboratories, Ltd. | ANDA 75-844 | 1/3/02 | |||
| Oxaprozin Tablets, 600 mg, Rx | Purepac Pharmaceutical Co. | ANDA 75-843 | 10/3/01 | 4/15/03 | ||
| Oxaprozin Tablets, 600 mg, Rx | Invamed Inc. | ANDA 75-842 | 4/12/01 | 4/13/01 | ||
| Oxilan, (Ioxilan) Injection, 300 mgI/mL and 350 mgI/mL, Rx | Guerbet LLC | NDA 20-316/SLR-016 | 1/6/02 | 1/23/03 | ||
| OXISTAT (oxiconazole nitrate) Cream and Lotion, 1%, | GlaxoSmithKline | NDA 19-828/S9 & 20-209/S5 | 1/23/04 | 1/29/04 | 2/2/04 | |
| Oxsoralen-Ultra (methosalen), USP, Capsules, 10 mg, Rx | ICN Pharmaceuticals, Inc. | NDA 19-600/S-006 & S-009 | 3/26/03 | 4/15/03 | 4/1/03 | |
| Oxycodone Extended-Release Tablets, 80mg, Rx | TEVA Pharmaceutical | ANDA 76-168 | 3/24/04 | 3/26/04 | ||
| Oxycodone Hydrochloride Tablets, 15 & 30mg, Rx | Amide Pharmaceutical | ANDA 76-636 | 2/6/04 | 2/12/04 | ||
| Oxycodone Hydrochloride Extended-Release Tablets, 10, 20 & 40mg, Rx Tentatively Approved | Impax Laboratories | ANDA 76-446 | 12/23/03 | |||
| Oxycodone Hydrochloride Extended-Release Tablets, 80 mg, Rx Tentatively Approved | Impax Laboratories | ANDA 76-318 | 9/4/03 | |||
| Oxycodone Hydrochloride Extended-Release Tablets, 80 mg, Rx Tentatively Approved | Teva Pharmaceuticals | ANDA 76-168 | 9/29/03 | |||
| Oxycodone Extended-Release Tablets, 10, 20 & 40mg, Rx | Endo Pharmaceuticals | ANDA 75-923 | 3/23/04 | 3/26/04 | ||
| Oxycodone Hydrochloride, 10, 20, 40 80 mg, Rx Tentatively Approved | Endo Pharmaceuticals, Inc. | ANDA 75-923 | 7/31/02 | |||
| Oxycodone and Acetaminophen Capsules, 5 mg/500 mg, Rx | Barr Laboratories | ANDA 40-304 | 10/2/00 | 10/30/00 | ||
| Oxycodone and Acetaminophen Capsules, 5 mg/500 mg, Rx | Amide Pharmaceuticals | ANDA 40-199 | 12/30/98 | 8/1/03 | ||
| Oxycodone and Acetaminophen Capsules USP,5 mg/500 mg. | Endo Pharmaceuticals, Inc. | ANDA 40-303 | 12/30/99 | 1/3/00 | 8/4/03 | |
| Oxycodone and Acetaminophen Capsules, 5 mg/500 mg, Rx | Mallinckrodt Chemical | ANDA 40-257 | 8/4/98 | 8/5/98 | 8/4/03 | |
| Oxycodone and Acetaminophen Tablets USP, 7.5 mg/500 mg & 10 mg/650, Rx | Watson Laboratories, Inc. | ANDA 40-371 | 12/29/00 | 2/27/01 | 1/17/02 | |
| Oxycodone and Acetaminophen Tablets, 5 mg/500 mg | Duramed Pharmaceuticals, Inc. | ANDA 40-289 | 3/16/99 | 3/22/99 | ||
| Oxycodone and Acetaminophen Tablets, 5 mg/325 mg, Rx | Duramed Pharmaceuticals | ANDA 40-272 | 6/30/98 | 7/1/98 | 3/16/99 | |
| Oxycodone and Aspirin Tablets USP, 4.5 mg/0.38 mg/325 mg | Halsey Drug Co | ANDA 40-260 | 7/17/98 | 7/17/98 | ||
| Oxycodone and Aspirin Tablets USP, 4.5 mg/0.38 mg/325 mg | Watson Laboratories, Inc. | ANDA 40-255 | 2/27/98 | 2/22/99 | ||
| Oxycodone and Acetaminophen Tablets, 5 mg/500 mg | Halsey Drug Co. | ANDA 40-219 | 1/22/98 | |||
| Oxycodone and Acetaminophen Tablets, 5 mg/325 mg | Amide Pharmaceutical, Inc. | ANDA 40-203 | 3/15/99 | 3/22/99 | 9/19/02 | |
| Oxycontin (oxycodone HCl) Controlled Release Tablets, | Purdue Pharma L. P. | NDA 20-553/S35 | 11/20/03 | 11/25/03 | ||
| Oxycontin (oxycodone HCl) Controlled Release Tablets | Purdue Pharma L. P. | NDA 20-553/S-01, 02, 04, & 06 | 3/15/00 | 4/9/02 | ||
| Oxycontin (oxycodone HCl) Controlled Release Tablets | Purdue Pharma L. P. | NDA 20-553/S-024 | 1/15/02 | 2/7/02 | 2/7/02 | |
| Oxycontin (Oxycodone Hydrochloride) Tablets, 10, 20, 40, 80, & 160 mg, Rx | Purdue Pharma L. P. | NDA 20-553/S022 | 7/25/01 | 7/26/01 | 7/26/01 | |
| Oxytrol (oxybutynin transdermal system) 3.9 mg, Rx | Watson Laboratories, Inc. | NDA 21-351 | 2/26/03 | 3/10/03 | 3/11/03 | |
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