Back to Drug Information Page
|
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 |
|---|---|---|---|---|---|---|
| Habistat (0.5% Chlorhexidine Gluconate) Solution & Towelettes, | SSL Americas, Inc. | NDA 18-300/S15 | 1/13/04 | 1/15/04 | ||
| Habistat (0.5% Chlorhexidine Gluconate) Solution & Towelettes, | SSL Americas, Inc. | NDA 18-300/S14 | 1/13/04 | 1/15/04 | ||
| Habitrol (nicotine) Transdermal System, | Novartis Consumer Health, Inc. | NDA 20-076/S25 | 1/21/04 | 1/22/04 | ||
| Habitrol (nicotine) Transdermal System, | Novartis Consumer Health, Inc. | NDA 20-076/S24 | 2/6/04 | 3/3/04 | ||
| Habitrol (nicotine transdermal system), 21, 14, & 7mg/day patches | Novartis Consumer Health, Inc. | NDA 20-076/S-021 | 7/15/02 | 7/24/02 | 7/16/02 | |
| Habitrol (nicotine transdermal system), 21, 14, & 7mg/day patches | Novartis Consumer Health, Inc. | NDA 20-076/S-020 | 7/12/02 | 7/15/02 | 7/15/02 | |
| Habitrol (nicotine transdermal system), 21, 14, & 7mg/day patches | Novartis Consumer Health, Inc. | NDA 20-076/S-011 | 11/12/99 | 12/30/99 | ||
| Halcion (triazolam) Tablets, 0.125 mg and 0.25 mg | Pharmacia & UpJohn | NDA 17-892/S-034 | 6/25/03 | 7/6/03 | ||
| Haldol (haloperidol) Tablets, Concentrate, Injection, and Haldol (haloperidol) Decanoate Injection, | The R.W. Johnson Pharmaceutical Research Institute | NDA 15-921/S76, 15-922/S66, 15-923/S72 & 18-701/S46 | 4/17/02 | |||
| Halfan (halofantrine hydrochloride) Tablets, 250 mg, Rx | GlaxoSmithKline | NDA 20-250/S-007, S-008 | 8/1/02 | 8/6/02 | 8/5/02 | |
| Haloperidol Injection, 5 mg/mL, Rx | Gensia Sicor Pharmaceuticals, Inc. | ANDA 76-035 | 8/29/01 | 4/16/03 | ||
| Haloperidol Injection, 5 mg/mL, Rx | Bedford Laboratories | ANDA 75-858 | 6/18/01 | 6/26/01 | ||
| Haloperidol Injection, 5 mg (base)/mL, Rx | American Pharmaceutical Partners, Inc. | ANDA 75-689 | 3/9/01 | 3/30/01 | ||
| Haloperidol Decanoate Injection, 50 mg (base)/mL & 100 mg (base)/mL (Multi-Dose Vials)., Rx | Apotex Corp. | ANDA 75-440 | 2/28/00 | 2/29/00 | ||
| Haloperidol Decanoate Injection, 50 mg (base)/mL & 100 mg (base)/mL (Single & Multi-Dose Vials). | Gensia Sicor Pharmaceuticals, Inc. | ANDA 75-393 | 5/11/99 | 5/18/99 | 7/11/01 | |
| Haloperidol Decanoate Injection, 100 mg (base)/mL, Rx | Bedford Laboratories | ANDA 75-305 | 9/28/98 | 9/29/98 | 9/25/02 | |
Haloperidol Decanoate Injection, 50 mg (base)/mL and 100 mg (base)/mL, (packaged in 1 mL ampules and 5 mL multiple-dose vials), Rx |
King Pharmaceuticals, Inc. | ANDA 75-176 | 2/9/00 | 2/11/00 | 1/2/02 | |
| Haloperidol Decanoate Injection50mg (base)/ml | Bedford Laboratories | ANDA 74-811 | 1/30/98 | 3/30 | ||
| Hectorol (Doxercalciferol) Capsules, 0.5 ug, Rx | Bone Care International | NDA 20-862/S6 | 4/23/04 | |||
| Hectorol (Doxercalciferol) Capsules, 2.5 mcg, Rx | Bone Care International | NDA 20-862 | 6/9/99 | 6/11/99 | 6/11/99 | 6/29/00 |
| Hectorol Indication:For the reduction of elevated iPTH levels in the management of secondary hyperparathyroidism in patients undergoing chronic renal dialysis. | ||||||
| Hectorol (doxercalciferol) Injection, Rx | Bone Care International | NDA 21-027/S7 | 11/26/03 | 12/4/03 | ||
| Hectorol IV, Rx | Bone Care International | NDA 21-027 | 4/6/00 | 4/13/00 | 4/13/00 | 12/21/00 |
| Helicosol (C-13 Urea) lyophilized powder, 125mg, Rx | Metabolic Solutions, Inc | NDA 21-092 | 12/17/99 | 12/27/99 | 12/27/99 | 10/11/01 |
| Helicosol Indication: Drug component of the medical device for Ez-HBT for the detection of active Helicobacter Pylori infection of the gastrointestinal tract. | ||||||
| Helidac Therapy (bismuth subsalicylate/metronidazole/tetracycline hydrochloride), Rx | Prometheus Labs | NDA 50-719/S7 | 4/27/03 | |||
| Helidac Therapy (bismuth subsalicylate/metronidazole/tetracycline hydrochloride), Rx | Prometheus Labs | NDA 50-719 & 50-719/S-006 | 12/12/02 | 1/30/03 | ||
| Heparine Sodium Injection and 0.9% Sodium Chloride injection | Baxter Healthcare | NDA 18-609 S33/18-609/S35 | 8/21/01 | |||
| Heparin Sodium in 0.9% Sodium Chloride Injection, in EXCELŽ Plastic Container., | B. Braun Medical Inc. | NDA 19-953/S12 | 4/13/04 | |||
| Heparin Sodium in 5% Dextrose Injection, in EXCELŽ Plastic Container., | B. Braun Medical Inc. | NDA 19-952/S12 | 4/13/04 | |||
| Heparine Sodium Injection, USP and Heparin Lock Flush Solution, USP, | American Pharmaceutical Partners, Inc. | NDA 17-029/S-099 | 3/22/02 | 4/8/02 | ||
| HEPSERA (adefovir dipivoxil) Tablets, 10 mg | Gilead Sciences, Inc. | NDA 21-449 | 9/20/02 | 9/24/02 | 9/23/02 | 1/31/03 |
| Herceptin (Trastuzumab) | Genentech, Inc | BLA 103792 / 5046 | 10/16/03 | 11/6/03 | ||
| Hespan (6% hydroxyethel starch in 0.9% sodium chloride injection) in Excel plastic container | B. Braun Medical Inc. | BN890105/15 | 3/19/03 | 8/19/03 | ||
| HIVID (zalcitabine) Tablets, | Hoffman-La Roche, Inc. | NDA 20-199/S-016 | 9/12/02 | 9/18/02 | 9/12/02 | |
| HIVID (zalcitabine) Tablets, | Hoffman-La Roche, Inc. | NDA 20-199/S-015 | 8/14/02 | 8/21/02 | 8/14/02 | |
| HIVID (zalcitabine) Tablets, | Hoffman-La Roche, Inc. | NDA 20-199/S-014 | 7/3/02 | 7/9/02 | 7/8/02 | |
| HMS (medrysone ophthalmic suspension), 1% | Allergan, Inc. | NDA 16-624/S-041 | 8/23/02 | 8/30/02 | 8/23/02 | |
| Humalog Mix 75/25, Rx | Eli Lilly | NDA 21-017/S18 | 4/21/04 | |||
| Humalog Mix 75/25, Rx | Eli Lilly | NDA 21-017/S6 & S15 | 4/23/04 | |||
| Humalog Mix 75/25, Rx | Eli Lilly | NDA 21-017/S13 | 11/19/03 | 11/25/03 | 12/2/03 | |
| Humalog Mix 75/25, Rx | Eli Lilly | NDA 21-017/S10 | 6/22/03 | 7/28/03 | ||
| Humalog Mix 75/25, Rx | Eli Lilly | NDA 21-017 | 6/30/03 | |||
| Humalog Mix 50/50, Rx | Eli Lilly | NDA 21-018/S11 | 11/19/03 | 11/25/03 | 12/2/03 | |
| Humalog Mix 50/50 & 75/25, Subcutaneous injection, Rx | Eli Lilly | NDA 21-018 NDA 21-017 |
12/22/99 | 1/3/00 | 1/3/00 1/3/00 |
6/19/01 |
| Humalog Mix Indication: Treatment of patients with diabetes mellitus for the control of hyperglycemia. | ||||||
| Humalog (insulin lispro [rDNA origin]) Injection, Rx | Eli Lilly | NDA 20-563/S46 | 4/21/04 | |||
| Humalog (insulin lispro [rDNA origin]) Injection, Rx | Eli Lilly | NDA 20-563/S44 | 11/19/03 | 11/25/03 | 12/2/03 | |
| Humalog (insulin lispro [rDNA origin]) Injection, Rx | Eli Lilly | NDA 20-563/S-041 | 9/29/03 | 10/9/03 | 10/8/03 | |
| Humalog (insulin lispro [rDNA origin]) Injection, Rx | Eli Lilly | NDA 20-563/S-040 | 6/24/03 | 7/6/03 | 7/8/03 | |
| Humalog (insulin lispro [rDNA origin]) Injection, Rx | Eli Lilly | NDA 20-563/S36 | 1/16/04 | 1/22/04 | 1/22/04 | |
| Humalog (insulin lispro [rDNA origin]) Injection, Rx | Eli Lilly | NDA 20-563/S32 | 4/1/03 | 4/16/03 | 4/18/03 | |
| Humalog (insulin lispro [rDNA origin]) Injection, Rx | Eli Lilly | NDA 20-563/S15 | 1/2/03 | 3/26/03 | ||
| Humalog (insulin lispro [rDNA origin]) Injection, Rx | Eli Lilly | NDA 20-563/S16 | 1/2/03 | 1/23/03 | ||
| Humalog (insulin lispro [rDNA origin]) Injection, Rx | Eli Lilly | NDA 20-563/S10, 11, 12, & 13 | 4/4/00 | 4/4/00 | 4/4/00 | |
| Human Secretin Injection, | ChiRhoClin, Inc. | NDA 21-256 | 4/9/04 | |||
| Humatrope [Somatropin, (rDNA origin) for injection], Rx | Lilly Research Laboratories | NDA 19-640/S-033 | 7/25/03 | 8/14/03 | 8/14/03 | |
| Humatrope [Somatropin, (rDNA origin) for injection], Rx | Lilly Research Laboratories | NDA 19-640/S-032 | 3/24/03 | 3/26/03 | ||
| Humatrope [Somatropin, (rDNA origin) for injection], Rx | Lilly Research Laboratories | NDA 19-640/S-031 | 12/4/02 | 12/9/02 | ||
| Humatrope [Somatropin, (rDNA origin) for injection], | Eli Lilly and Co. | NDA 19-640/S-025 | 6/10/02 | 6/14/02 | ||
| Humulin, | Eli Lilly and Co. | NDA 20-100/S21 | 10/23/03 | 11/25/03 | ||
| Humulin Mixture 70/30 Injection, | Eli Lilly and Co. | NDA 19-717/S58 | 4/22/04 | |||
| Humulin Mixture 70/30 Injection, | Eli Lilly and Co. | NDA 19-717/S54 | 11/19/03 | 12/2/03 | 12/2/03 | |
| Humulin Mixture 70/30 Injection, | Eli Lilly and Co. | NDA 19-717/S52 | 6/22/03 | 7/6/03 | 7/8/03 | |
| Humulin Mixture 70/30 Injection, | Eli Lilly and Co. | NDA 19-717/S50 | 11/17/03 | 11/25/03 | 12/2/03 | |
| Humulin Mixture 70/30 Injection, | Eli Lilly and Co. | NDA 19-717/S41 | 10/3/02 | 10/11/01 | 10/4/02 | |
| Humulin 70/30 (70% human insulin isophane suspension and 30% human insulin injection, [rDNA origin]). | Eli Lilly and Company | NDA 19-717/S-030 | 11/1/02 | 11/19/02 | ||
| Humulin L Lente (human insulin [rDNA origin] zinc suspension), Rx | Eli Lilly and Company | NDA 19-377/S-036 | 4/18/03 | |||
| Humulin N, Humulin 70/30 & Humalog, | Eli Lilly and Co. | NDA 18-781/S-057, 19-717/S-032 & 20-563/S-027 | 2/12/03 | 2/25/03 | 3/11/03 | |
| Humulin N (human insulin [rDNA origin])., | Eli Lilly and Co. | 18-781/S76 | 4/21/04 | |||
| Humulin N (human insulin [rDNA origin])., | Eli Lilly and Co. | 18-781/S74 | 11/19/03 | 11/25/03 | 12/2/03 | |
| Humulin N (human insulin [rDNA origin]). | Eli Lilly and Co. | 18-781/S-072 | 6/22/03 | 7/6/03 | 7/8/03 | |
| Humulin N (human insulin [rDNA origin])., | Eli Lilly and Co. | 18-781/S60 & S70 | 11/20/03 | 11/25/03 | ||
| Humulin N (human insulin [rDNA origin]). | Eli Lilly and Co. | 18-781/S-054 | 11/5/02 | 11/19/02 | ||
| Humulin N/R Mixture 70/30 Injection, | Eli Lilly and Co. | NDA 19-717/S35 | 2/3/02 | 5/16/02 | ||
| Humulin R (human insulin [rDNA origin] injection), Rx | Eli Lilly and Company | NDA 18-780/S80 | 11/10/03 | 11/25/03 | 12/1/03 | |
| Humulin R (human insulin [rDNA origin] injection) U-500, Rx | Eli Lilly and Company | NDA 18-780/S-066 | 4/14/03 | |||
| Humulin R (human insulin injection, USP, [rDNA origin]), Rx | Eli Lilly and Company | NDA 18-780/S67 & S78 | 2/10/03 | 2/12/03 | 2/13/03 | |
| Humulin U Ultralente (human insulin [rDNA origin] extended zinc suspension), Rx | Eli Lilly and Company | NDA 19-571/S-029 | 4/18/03 | |||
| Hycamtin (topotecan hydrochloride) Injection, Rx | SmithKline Beecham | NDA 20-671/S-012 | 5/9/03 | 7/9/03 | 7/9/03 | |
| Hycamtin (topotecan hydrochloride) Injection, 4 mg., Rx | SmithKline Beecham | NDA 20-671/S-011 | 3/11/03 | 4/1/03 | ||
| Hycamtin (topotecan hydrochloride) for Injection, 4 mg., Rx Pediatric Study | SmithKline Beecham | NDA 20-671/S-010 | 2/26/03 | |||
| Hycamtin (topotecan hydrochloride) for Injection, 4 mg., Rx | SmithKline Beecham | NDA 20-671/S-009 | 3/6/02 | 3/12/02 | ||
| Hycamtin (topotecan hydrochloride) for Injection, Rx | SmithKline Beecham Pharmaceuticals | NDA 20-671/S-004 | 11/30/98 | 1/12/99 | 1/12/99 | 3/13/00 |
| Hycamtin Indication: This supplemental new drug application provides for the useof Hycamtin in the treatment of small cell lung cancer sensitive disease after failure of first-line chemotherapy. In clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the phase 3 study) or at least 90 days (in the phase 2 studies) after chemotherapy. | ||||||
| Hydralazine Hydrochloride Injection USP, 20 mg/mL, Rx | American Pharmaceutical Partners, Inc. | ANDA 40-388 | 3/13/01 | 3/30/01 | ||
| Hydralazine Hydrochloride Injection USP, 20 mg/mL, Rx | Gensia Sicor Pharmaceutcials, Inc. | ANDA 40-373 | 2/23/00 | 2/24/00 | ||
| HYDREA (hydroxyurea) Capsules, USP | Bristol-Myers Squibb Company | ANDA 16-295/S37 | 2/19/04 | 3/3/04 | 4/5/04 | |
| HYDREA and DROXIA (hydroxyurea capsules, USP) | Bristol-Myers Squibb Company | ANDA 16-295/S-034 | 4/4/01 | 10/17/02 | ||
Hydrochlorothiazide Capsules, 12.5 mg, Rx |
Vintage Pharmaceuticals, Inc. | ANDA 75-907 | 9/17/02 | |||
Hydrochlorothiazide Capsules, 12.5 mg, Rx |
Mylan Pharmaceuticals Inc. | ANDA 75-640 | 1/28/00 | 2/4/00 | ||
Hydrochlorothiazide Tablets, 25 7 50 mg, Rx |
Vintage Pharmaceuticals Inc. | ANDA 40-412 | 3/29/02 | 4/9/03 | ||
| Hydrocodone Bitartrate and Acetaminophen Elixir, 7.5 mg/500 mg per 15 mL, Rx | KV Pharmaceutical Company | ANDA 40-366 | 1/23/02 | |||
| Hydrocodone Bitartrate and Acetaminophen Elixir, 7.5 mg/500 mg per 15 mL | Pharmaceutical Associates, Inc. | ANDA 40-182 | 3/13/98 | 2/18/99 | ||
| Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg, Rx | Vintage Pharmaceuticals | ANDA 40-520 | 10/30/03 | |||
| Hydrocodone Bitartrate and Acetaminophen Oral Solution, 10 mg/500 mg, Rx | Mallinckrodt, Inc. | ANDA 40-508 | 8/29/03 | |||
| Hydrocodone Bitartrate and Acetaminophen Oral Solution, Rx | Mikart, Inc. | ANDA 40-482 | 9/25/03 | |||
| Hydrocodone Bitartrate and Acetaminophen Oral Solution USP, 7.5 mg/500 mg, Rx | Mallinckrodt, Inc. | ANDA 40-418 | 6/27/01 | 1/24/02 | 1/24/02 | 1/24/02 |
| Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/660 mg, Rx | Andrx Pharmaceuticals | ANDA 40-495 | 5/28/03 | |||
| Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/750 mg, Rx | Andrx Pharmaceuticals | ANDA 40-494 | 5/28/03 | |||
| Hydrocodone Bitartrate and Acetaminophen Tablets, 5 mg/500 mg, Rx | Andrx Pharmaceuticals | ANDA 40-493 | 5/28/03 | |||
| Hydrocodone Bitartrate and Acetaminophen Tablets, 5 mg/325 mg, Rx | Able Laboratories, Inc. | ANDA 40-478 | 11/8/02 | |||
| Hydrocodone Bitartrate and Acetaminophen Tablets, 5 mg/500 mg, Rx | Able Laboratories, Inc. | ANDA 40-477 | 11/6/02 | |||
| Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/650 mg, Rx | Able Laboratories, Inc. | ANDA 40-476 | 10/23/02 | |||
| Hydrocodone Bitartrate and Acetaminophen Tablets USP, 7.5 mg/650 mg, Rx | Able Laboratories, Inc. | ANDA 40-474 | 1/2/03 | |||
| Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, Rx | Able Laboratories, Inc. | ANDA 40-473 | 11/6/02 | |||
| Hydrocodone Bitartrate and Acetaminophen Tablets USP, 7.5 mg/750 mg, Rx | Able Laboratories, Inc. | ANDA 40-469 | 10/25/02 | |||
| Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/750 mg, Rx | Mallinckrodt, Inc. | ANDA 40-468 | 10/31/02 | |||
| Hydrocodone Bitartrate and Acetaminophen Tablets USP, 7.5 mg/325 mg & 10 mg/325 mg, Rx | Able Laboratories, Inc. | ANDA 40-464 | 10/23/02 | |||
| Hydrocodone Bitartrate and Acetaminophen Tablets USP, 7.5 mg/325 mg, Rx | Mikart, Inc. | ANDA 40-432 | 1/22/03 | |||
| Hydrocodone Bitartrate and Acetaminophen Tablets USP, 7.5 mg/325 mg, Rx | Mallinckrodt, Inc. | ANDA 40-409 | 10/20/00 | 10/30/00 | ||
| Hydrocodone Bitartrate and Acetaminophen Tablets USP, 7.5 mg/325 mg, Rx | Mallinckrodt, Inc. | ANDA 40-405 | 9/8/00 | 10/30/00 | ||
| Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/325 mg 10 mg/325 mg per tablet, Rx | Mallinckrodt, Inc. | ANDA 40-400 | 7/26/00 | 10/30/00 | ||
| Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/660 mg, Rx | Vintage Pharmaceuticals Inc. | ANDA 40-358 | 5/31/00 | 6/6/00 | ||
| Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/500 mg, Rx | Vintage Pharmaceuticals Inc. | ANDA 40-356 | 5/31/00 | 6/6/00 | ||
| Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/325 mg, Rx | Vintage Pharmaceuticals Inc. | ANDA 40-355 | 5/31/00 | 6/6/00 | ||
| Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, Rx | Barr Laboratories, Inc. | ANDA 40-309 | 7/26/00 | 10/30/00 | 8/4/03 | |
| Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/500 mg and 7.5 mg/750 mg, Rx only | Barr Laboratories Inc. | ANDA 40-308 | 7/26/00 | 10/30/00 | 8/4/03 | |
| Hydrocodone Bitartrate and Acetaminophen Tablets USP, 2.5 mg/500 mg; 7.5 mg/500 mg; 7.5 mg/650 mg; and 10 mg/650 mg, Rx | Barr Laboratories Inc. | ANDA 40-307 | 7/26/00 | 10/30/00 | 1/17/02 | |
| Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/400 mg, 7.5 mg/400 mg, 10 mg/400 mg, Rx | Endo Pharmaceuticals | ANDA 40-288 | 11/27/98 | 11/30/98 | ||
| Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/500 mg, 7.5 mg/750 mg, Rx | Endo Pharmaceuticals | ANDA 40-281 | 9/30/98 | 9/30/98 | 8/4/03 | |
|
Hydrocodone Bitartrate and Acetaminophen
Tablets USP, 7.5 mg/500 mg, 7.5 mg/650 mg, 10 mg/650 mg, Rx |
Endo Pharmaceuticals | ANDA 40-280 | 9/30/98 | 9/30/98 | ||
| Hydrocodone Bitartrate and Acetaminophen Tablets,7.5 mg/325 mg & 10 mg/325 mg, Rx | UCB Pharma, Inc. | ANDA 40-248 | 4/28/20 | 4/28/00 | ||
|
Hydrocodone Bitartrate and Acetaminophen
Tablets USP, 7.5 mg/500 mg, and 10 mg/500 mg, Rx |
Mallinckrodt Chemical, Inc. | ANDA 40-201 | 2/27/98 | 2/18/99 | ||
| Hydrocodone Bitartrate and Ibuprofen Tablets USP, 5 mg/200 mg, Rx (Tentative Approval of 7.5 mg/200 mg dosage) | Interpharm Inc. | ANDA 76-642 | 3/18/04 | |||
| Hydrocodone Bitartrate and Ibuprofen Tablets USP, 7.5 mg/200 mg, Rx | Andrx Pharmaceuticals | ANDA 76-604 | 12/31/03 | |||
| Hydrocodone Bitartrate and Ibuprofen Tablets USP, 7.5 mg/200 mg, Rx | Teva Pharmaceuticals | ANDA 76-023 | 4/11/03 | |||
| Hydrocodone Bitartrate and Homatropine methylbromide Tablets USP, 5 mg/1.5 mg, Rx | Amide Pharmaceutical, Inc. | ANDA 40-295 | 12/1/00 | 3/5/01 | ||
| Hydrocodone Bitartrate & Homatropine Methylbromide Syrup, 5 mg & 1.5 mg | Halsey Drug Company, Inc. | ANDA 40-285 | 7/19/99 | 7/29/99 | ||
| Hydrocortisone Acetate Cream USP, 2.5% | Ferndale Laboratories, Inc. | ANDA 40-259 | 7/29/99 | 8/4/99 | 1/17/02 | |
| Hydrocortisone Butyrate Topical Solution, 0.1% | Taro | ANDA 76-364 | 1/14/03 | 1/15/04 | ||
| Hydrocortisone Cream USP, 2.5%, Rx | Vintage Pharmaceuticals | ANDA 40-503 | 3/12/04 | |||
| Hydrocortisone Lotion USP, 2.5%, Rx | Vintage Pharmaceuticals | ANDA 40-417 | 7/30/03 | |||
| Hydrocortisone Lotion USP, 2.5%, Rx | Altana, Inc. | ANDA 40-351 | 7/25/00 | 10/30/00 | ||
| Hydrocortisone Lotion USP, 2.5%, Rx | Thames Pharmcal | ANDA 40-247 | 7/23/99 | 8/6/99 | ||
| Hydrocortisone Valerate Cream USP, 0.2%, Rx | Clay-Park Labs, Inc. | ANDA 75-666 | 5/24/00 | 5/31/00 | ||
| Hydrocortisone Valerate Cream USP, 0.2%, Rx | Copley Pharmaceutical | ANDA 74-489 | 8/12/98 | 8/14/98 | 8/24/01 | |
| Hydrocortisone Valerate Cream USP, 0.2%, Rx | Taro Pharmaceuticals USA | ANDA 75-042 | 8/25/98 | 8/28/98 | 8/6/03 | |
| Hydrocortisone Valerate Ointment USP, 0.2%, Rx | Taro Pharmaceuticals USA | ANDA 75-043 | 8/25/98 | 8/28/98 | 8/24/01 | |
| Hydrocortisone Valerate Ointment USP, 0.2%, Rx | Altana Inc. | ANDA 75-085 | 7/31/01 | |||
| Hydrocortisone Valerate Ointment USP, 2.5%, Rx | Thames Pharmacal Co., Inc. | ANDA 40-310 | 12/29/00 | 2/27/01 | 8/4/03 | |
| Hydromorphone Hydrochloride Injection, Rx | Faulding Pharmaceutical | ANDA 76-444 | 4/25/03 | |||
| Hydromorphone Hydrochloride Oral Solution, 5 mg/5 mL, Rx | Roxane Laboratories | ANDA 74-653 | 7/29/98 | 8/5/98 | ||
| Hydromorphone Hydrochloride Tablets USP, 8 mg, Rx | Roxane Laboratories | ANDA 74-597 | 7/29/98 | 7/30/98 | ||
| Hydroxychloroquine Sulfate Tablets USP, 200 mg | Mylan Phamaceuticals | ANDA 40-274 | 5/29/98 | 5/29/98 | 8/4/03 | |
| Hydroxyurea Capsules USP, 500 mg, Rx | Barr Laboratories | ANDA 75-143 | 10/16/98 | 10/20/98 | 9/25/02 | |
| Hydroxyurea Capsules USP, 500 mg, Rx | Duramed Pharmaceuticals | ANDA 75-020 | 7/30/98 | 8/5/98 | 9/25/02 | |
| Hydroxyurea Capsules USP, 500 mg, Rx | Par Pharmaceuticals | ANDA 75-340 | 2/24/99 | 3/4/99 | ||
| Hydroxyurea Tablets USP, 1000 mg, Rx | Barr Laboratories | ANDA 75-734 | 8/29/00 | 11/7/00 | ||
| Hydroxyzine Hydrochloride Syrup USP, 10 mg/5 mL, Rx | Vintage Pharmaceuticals, Inc. | ANDA 40-391 | 4/10/02 | 4/8/03 | ||
| Hypaque-Cysto (brand of diatrizoate meglumine), | Amersham Health | NDA 16-403/SLR-071 | 9/30/02 | 10/2/02 | ||
| Hytrin (terazosin HCl) 1, 2, 5 and 10 mg Tablets (NDA 19-057) & Hytrin (terazosin HCl) 1, 2, 5 and 10 mg Soft Elastic Capsules (NDA 20-347). | Abbott Laboratories | NDA 19-057/S15 & 20-347/S6 | 1/23/02 | 2/5/02 | ||
| Hyzaar (losartan potassium/hydrochlorothiazide), | Merck & Co., Inc. | NDA 20-387/S-013
& S-015 & S-027 |
9/30/03 | 10/10/03 | 10/10/03 | 11/25/03 |
| Hyzaar (losartan potassium/hydrochlorothiazide) Tablets, 50/12.5 and 100/25 mg. | Merck & Co., Inc. | NDA 20-387/S-024 | 11/7/02 | 11/18/02 | ||
| Hyzaar (losartan potassium/hydrochlorothiazide) Tablets, 50-12.5 mg | Merck Research Laboratories | NDA 20-387/S6 | 8/24/98 | 12/3/01 | ||
| Hyzaar (losartan potassium/hydrochlorothiazide) Tablets, 50-12.5 mg | Merck Research Laboratories | NDA 20-387/S8 | 11/10/98 | 12/3/01 | ||
| Hyzaar 50-12.5 (losartan potassium/hydrochlorothiazide) Tablets, 50-12.5 mg | Merck Research Laboratories | NDA 20-387/S10 | 8/25/98 | 12/3/01 | ||
| Hyzaar 50 (losartan potassium/hydrochlorothiazide) Tablets, 50-12.5 mg | Merck Research Laboratories | NDA 20-387/S-011 | 11/24/98 | 3/13/00 | ||
| Hyzaar 50 (losartan potassium/hydrochlorothiazide) Tablets, 50-12.5 mg & 100-25 mg | Merck Research Laboratories | NDA 20-387/S-012 | 6/9/99 | 7/11/00 | ||
Some of our documents are in
P
ortable
D
ocument
F
ormat (PDF) to retain the original format. To view or print
these documents, you must use the Adobe Acrobat viewer. Acrobat is free and
available directly from Adobe's website with full installation instructions.
