|
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 |
|---|---|---|---|---|---|---|
| DMSA (Kit for the preparation of Tc99m Succimer for Injection), Rx | Amersham Health | NDA 17-944/S-018 | 11/24/03 | 11/25/03 | ||
| Dacarbazine for Injection USP, 200 mg/vial, Rx | Faulding Pharmaceutical Co. | ANDA 75-940 | 10/18/01 | 4/16/03 | ||
| Dacarbazine for Injection USP, 500 mg/vial, Rx | Bedford Laboratories | ANDA 75-812/S3 | 10/31/02 | |||
| Dacarbazine for Injection USP, 200 mg/vial, Rx | Bedford Laboratories | ANDA 75-812 | 6/15/01 | 6/26/01 | ||
| Dacarbazine for Injection USP, 100 mg/vial & 200 mg/vial | American Pharmaceutical Partners, Inc. | ANDA 75-371 | 8/27/99 | 9/2/99 | ||
| Dacarbazine for Injection USP, 200 mg/vial, Rx | Gensia Sicor Pharmaceuticals | ANDA 75-259 | 8/27/98 | 9/2/98 | ||
| Dalmane (flurazepam hydrochloride) Capsules, 15 mg and 30 mg | ICN Pharmaceuticals | NDA 16-721/S-074 | 6/14/01 | 11/22/02 | ||
| Daraprim (pyrimethamine) Tablets, 25 mg, Rx | GlaxoSmithKline | NDA 8-578/S16 | 11/18/03 | 11/25/03 | 12/1/03 | |
| Daraprim (pyrimethamine) Tablets, 25 mg, Rx | GlaxoSmithKline | NDA 8-578/S-015 | 10/10/02 | 10/21/02 | 10/10/02 | |
| Darvon Compound 65 (propoxyphene hydrochloride, aspirin and caffeine) Capsule, Darvon (propoxyphene hydrochloride) Capsules, Darvon N (propoxyphene napsylate) Tablets | Lilly Reasearch Laboratories | NDA 10-996/S-061, 10-997/S-043 & 16-862/S-033 | 8/1/02 | 8/14/02 | ||
| Daunorubicin Hydrochloride for Injection, 5 mg/ml, 4ml vials, Rx | Bedford Laboratories | NDA 50-731 | 1/30/98 | 1/7/99 | ||
| Daunorubicin Hydrochloride for Injection, 20 mg (base)/single dose vial, Rx | Bigmar | ANDA 65-000 | 5/25/99 | 5/26/99 | ||
| Daunorubicin Hydrochloride for Injection, 20 mg (base)/single dose vial, Rx | Gensia Sicor | ANDA 64-212 | 6/23/98 | 6/26/98 | ||
| Daunorubicin Hydrochloride Injection, 5 mg (base)/mL, (packaged in 20 mg (base)/4 mL and 50 mg (base)/10 mL single-dose vials), Rx | Gensia Sicor Pharmaceuticals, Inc. | ANDA 65-035 | 1/24/00 | 2/4/00 | ||
| Daunorubicin Hydrochloride Injection, 5 mg (base)/mL, (packaged in 20 mg (base)/4 mL single-dose vials), Rx | SuperGen, Inc. | ANDA 65-034 | 11/20/01 | 10/10/02 | ||
| DaunoXome (daunorubicin citrate liposome injection), | Gilead Sciences, Inc. | NDA 50-704/S-008 | 2/21/02 | 2/22/02 | ||
| Daypro ALTA (oxaprozin potassium) Tablets, 600mg | Pharmacia Corporation | NDA 20-776 | 10/17/02 | 10/21/02 | 11/19/02 | |
| Daypro (Oxaprozin) Caplets, 600 mg | G.D. Searle & Co. | NDA 18-841/S012 & 16 | 1/25/02 | 2/4/02 | 2/4/02 | Daypro (oxyprozin) Caplets, 600 mg | Pharmacia Corporation | NDA 18-841/S-020 | 4/9/03 | 4/16/03 | 4/16/03 |
| DDAVP (desmopressin acetate) Nasal Spray, Injection & Tablets, Rx | Aventis Pharmaceuticals | NDA 17-922/S31, 18-938/S19 & 19-955/S5 | 11/12/03 | 11/25/03 | ||
| DDAVP (desmopressin acetate) Injection, 4 µg/mL | Aventis Pharmaceutical Products | NDA 18-938/S-017 | 8/8/02 | 8/12/02 | ||
| Declomycin (demeclocycline hydrochloride) Tablets, Rx | ESP Pharma | NDA 50-261/S97 | 12/18/03 | 12/22/03 | ||
| Declomycin (demeclocycline hydrochloride) Tablets, Rx | ESP Pharma | NDA 50-261/S94 | 12/18/03 | 12/22/03 | ||
| Declomycin (demeclocycline hydrochloride) Tablets, Rx | Lederle Laboratories | NDA 50-261/S-095 | 5/1/03 | 7/9/03 | ||
| Deferoxamine Mesylate Injection, Rx | Abbott Laboratories | ANDA 76-019 | 3/17/04 | 3/19/04 | ||
| DEFINITY Vial for (Perflutren Lipid Microsphere) Injectable Suspension, Rx | Bristol-Myers Squibb Medical Imaging, Inc. | NDA 21-064/SCM-004 | 1/30/03 | 2/12/03 | ||
| DEFINITY Vial for (Perflutren Lipid Microsphere) Injectable Suspension, Rx | Bristol-Myers Squibb Medical Imaging, Inc. | NDA 21-064/SLR-002 | 7/8/02 | 7/9/02 | ||
| Definity, Rx | Bristol-Myers Squibb Medical Imaging, Inc. | NDA 21-064/SLR-001 | 2/21/02 | 2/21/02 | ||
| Definity (perflutren Lipid Microsphere) Injectable Suspension, Rx | DuPont Pharmaceuticals Company | NDA 21-064 | 7/31/01 | 05/08/03 | 11/1/01 | |
| Definity Indications: Use of activated Definity (perflutren Lipid Microsphere) Injectable Suspension in patients with suboptimal echocardiograms to opacity the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. | ||||||
| Delestrogen (estradiol valerate) Injection, USP | King Pharmaceuticals | NDA 9-402/S37 & S39 | 12/12/03 | 12/16/03 | 12/16/03 | |
| Delflex Standard and Low Magnesium and Delflex PD Solution Low Calcium/Low Magnesium Peritoneal Solution, | Fresenius Medical | NDA 18-883/S28 & 20-171/S10 | 11/26/03 | 12/2/03 | ||
| Delsym (Dextromethorphan Polistirex) Extended-Release Suspension | Celltech Americas, Inc. | NDA 18-658/S015 | 1/24/02 | 2/4/02 | ||
| Demeclocycline Hydrochloride Tablets, 150 & 300 mg, Rx | IMPAX Laboratories | ANDA 65-094 | 3/22/04 | |||
| Demerol (meperidine HCl) Tablets & Syrup, Rx | Sanofi-Synthelabo | NDA 5-010/S-048 | 5/15/03 | 7/9/03 | ||
| Demerol (meperidine HCl, USP), Rx | Sanofi-Synthelabo | NDA 5-010/S-047 | 2/26/03 | 3/10/03 | ||
| Denavir (penciclovir) cream, 1%, Rx | Novartis Consumer Health, Inc. | NDA 20-629/S-009 | 4/8/03 | 4/18/03 | 4/18/03 | |
| Denavir (penciclovir) cream, 1%, Rx | Novartis Consumer Health, Inc. | NDA 20-629/S-008 | 10/10/02 | 10/16/03 | 10/16/03 | |
| Depacon (Valproate Sodium) Injection, Rx | Abbott Laboratories | NDA 20-593/S-006 | 1/24/02 | 1/25/02 | 1/25/02 | |
| Depakene Capsules, Syrup, Tablets, Sprinkle Capsules, and Depakote ER Tablets, Rx | Abbott Laboratories | NDA 18-081/S-038, 18-082/S-024, 18-723/S-029, 19-680/S-015, 20-593/S-009 & 21-168/S-003 | 12/12/02 | 1/29/03 | ||
| Depakote ER (divalproex) Tablets, Rx | Abbott Laboratories | NDA 21-168/S7 | 8/14/03 | 8/15/03 | 9/25/03 | |
| Depakote ER (divalproex) Extended-Release Tablets, Rx | Abbott Laboratories | NDA 20-782 & 21-168/S4 | 12/20/02 | 1/29/03 | 4/4/03 | |
| Depakote ER (divalproex) Tablets, Rx | Abbott Laboratories | NDA 21-168/S1 | 5/31/02 | 6/3/02 | 5/31/02 | |
| Depakote ER (divalproex sodium extended-release) Tablets, 500mg, Rx | Abbott Laboratories | NDA 21-168 | 8/4/00 | 8/17/00 | 8/17/00 | 12/15/03 |
| DepoCyt (Cytarabine Liposomal) Injection, Rx | SkyePharma Inc. | NDA 21-041/S8 & S10 | 10/2/03 | 10/9/03 | ||
| DepoCyt (Cytarabine Liposomal Injection), 10 mg/mL injection, Rx | DepoTech Corporation | NDA 21-041 | 4/1/99 | 4/5/99 | 4/5/99 | 7/5/02 |
| Derma-Smoothe/FS (Fluocinolone Acetonide Topical Oil), Rx | Hill Dermaceuticals, Inc. | NDA 19-452/S-018 | 4/13/03 | |||
| Derma-Smoothe/FS (Fluocinolone Acetonide Topical Oil), Rx | Hill Dermaceuticals, Inc. | NDA 19-452/S-17 | 10/10/01 | 11/5/01 | 11/5/01 | 11/14/01 |
| Derma-Smoothe/FS (Fluocinolone Acetonide Topical Oil), Rx | Hill Dermaceuticals, Inc. | NDA 19-452/S-015 | 8/19/99 | 9/24/99 | 8/24/99 | 7/3/00 |
| Derma-Smoothe/FS Indication:This supplement approved the treatment of atopic dermatitis in pediatric patients 6 years and older. | ||||||
| Desferal (deferoxamine mesylate, USP) Injection, | Novartis Pharmaceutical Company | NDA 16-267/S-039 | 2/14/02 | 3/8/02 | ||
| Desferal (deferoxamine mesylate, USP) Injection, | Novartis Pharmaceutical Company | NDA 16-267/S-034 | 4/9/01 | 10/16/02 | ||
| Desmopressin Acetate Injection,4 mcg/mL (packaged in 1 mL ampules), Rx | Abbott Laboratories | ANDA 75-220 | 8/28/00 | 10/31/00 | ||
| Desmopressin Acetate Injection,4 mcg/mL (packaged in 10 mL vials), Rx | Bedford Laboratories | ANDA 74-575 | 2/18/00 | 2/24/00 | ||
| Desmopressin Acetate Injection (Preservative-free),4 mcg/mL (packaged in 1 mL ampules), Rx | Bedford Laboratories | ANDA 74-574 | 2/18/00 | 2/24/00 | ||
| Desmopressin Acetate Nasal Solution, 0.01% | Ferring Pharmaceuticals | 21-333/S1 | 9/4/03 | 9/25/03 | 9/25/03 | |
| Desmopressin Acetate Nasal Solution, 0.01% | Bausch & Lomb Pharmaceuticals, Inc. | ANDA 74-830 | 1/25/99 | 1/25/99 | 4/22/03 | |
| Desmopressin Acetate Nasal Spray, Rx | Ferring Pharmaceuticals Inc. | NDA 21-333 | 9/16/02 | 9/20/02 | 9/17/02 | |
| Desogestrel & Ethinyl Estradiol Tablets, Rx | Barr Laboratories | ANDA 76-455 | 2/24/04 | 4/15/03 | ||
| Desogestrel & Ethinyl Estradiol Tablets, 0.15 mg & 0.03, respectively, Rx Tentatively Approved | Duramed Pharmaceuticals | ANDA 75-863 | 11/29/01 | 4/15/03 | ||
| Desogestrel & Ethinyl Estradiol Tablets, 0.15 mg & 0.03, respectively | Duramed Pharmaceuticals | ANDA 75-256/S7 | 06/19/02 | 8/24/99 | 8/6/03 | |
| Desogestrel & Ethinyl Estradiol Tablets, 0.15 mg & 0.03, respectively | Duramed Pharmaceuticals | ANDA 75-256/S6 | 07/27/01 | 8/24/99 | 8/6/03 | |
| Desogestrel & Ethinyl Estradiol Tablets, 0.15 mg & 0.03, respectively | Duramed Pharmaceuticals | ANDA 75-256/S5 | 07/27/01 | 8/24/99 | 8/6/03 | |
| Desogestrel & Ethinyl Estradiol Tablets, 0.15 mg & 0.03, respectively | Duramed Pharmaceuticals | ANDA 75-256/S4 | 07/11/01 | 8/24/99 | 8/6/03 | |
| Desogestrel & Ethinyl Estradiol Tablets, 0.15 mg & 0.03, respectively | Duramed Pharmaceuticals | ANDA 75-256/S3 | 11/14/01 | 8/24/99 | 8/6/03 | |
| Desogestrel & Ethinyl Estradiol Tablets, 0.15 mg & 0.03, respectively | Duramed Pharmaceuticals | ANDA 75-256/S2 | 06/28/01 | 8/24/99 | 8/6/03 | |
| Desogestrel & Ethinyl Estradiol Tablets, 0.15 mg & 0.03, respectively | Duramed Pharmaceuticals | ANDA 75-256/S1 | 10/28/99 | 8/24/99 | 8/6/03 | |
| Desogestrel & Ethinyl Estradiol Tablets, 0.15 mg & 0.03, respectively | Duramed Pharmaceuticals | ANDA 75-256 | 8/12/99 | 8/24/99 | 8/6/03 | |
| Desonide Lotion, 0.05%, Rx | Altana Inc. | ANDA 75-860 | 3/19/02 | 4/10/03 | ||
| Desonide Ointment, 0.05%, Rx | Altana Inc. | ANDA 75-751 | 3/12/01 | 3/30/01 | 1/17/02 | |
| Desoximetasone Cream USP, 0.25% | Clay Park Labs, Inc. | ANDA 76-510 | 6/1/03 | |||
| Desoximetasone Ointment USP, 0.25% | Altana Inc. | ANDA 73-440 | 4/1/98 | 2/22/99 | ||
| Desoximetasone Gel+- USP, 0.5% | Taro Pharmaceuticals USA, Inc. | ANDA 74-904 | 7/14/98 | 7/14/98 | 3/16/99 | |
| Desoxyn (methamphetamine HCl) Tablets and Desoxyn (methamphetamine HCl) Gradumet Tablets, 5 mg & 5 mg, 10 mg, and 15 mg, Rx | Abbott Laboratories | NDA 5-378/S-020 | 12/6/01 | 4/3/03 | ||
| Desyrel (trazodone hydrochloride) Tablets, 50 mg, 100 mg, 150 mg, and 300 mg | Bristol-Myers Squibb | NDA 18-207/S29 | 3/17/04 | 3/19/04 | ||
|
Detrol LA Extended Release Capsules, Rx |
Pfizer | NDA 21-228/S6 | 4/14/04 | |||
|
Detrol LA Extended Release Capsules, Rx |
Pharmacia and Upjohn | NDA 21-228/S5 | 1/15/04 | 1/22/04 | ||
|
Detrol LA Extended Release Capsules, Rx |
Pharmacia and Upjohn | NDA 21-228/S4 | 7/21/03 | 7/28/03 | ||
| Detrol LA Capsules, 2 and 4 mg extended release, Rx | Pharmacia and Upjohn | NDA 21-228/S1 | 4/27/01 | 5/1/03 | ||
| Detrol LA Capsules, 2 and 4 mg extended release, Rx | Pharmacia and Upjohn | NDA 21-228 | 12/22/00 | 1/9/01 | 1/9/01 | 2/11/04 |
| Detrol Indications: overactive bladder with symptoms of urge urinary incontinence, urgency and frequency | ||||||
| Detrol (Tolterodine Tartrate) Tablets, Rx | Pharmacia and Upjohn | NDA 20-771/S11 | 1/5/04 | 1/14/04 | ||
| Detrol (Tolterodine Tartrate) Tablets, Rx | Pharmacia and Upjohn | NDA 20-771/S-010 | 7/21/03 | 7/28/03 | ||
| Detrol (Tolterodine Tartrate) Tablets, 1 and 2 mg, Rx | Pharmacia and Upjohn | NDA 20-771/S-004 | 4/6/01 | 4/9/01 | 4/9/01 | |
| Detrol (Tolterodine Tartrate), 1 and 2 mg | Pharmacia and Upjohn | NDA 20-771 | 3/25/98 | 9/24/98 | 6/25/98 | 7/3/00 |
| Dexamethasone Sodium Phosphate Injection, 10 mg, Rx | American Pharmaceutical | ANDA 40-491 | 4/11/03 | |||
| Dexmethylphenidate HCI Tablets | Celgene | NDA 21-278 | 11/13/01 | 1/14/02 | ||
| Dextroamphetamine Sulfate Extended Release Capsules USP, 5, 10 & 15mg, Rx | Mallinckrodt, Inc. | ANDA 76-353 | 5/6/03 | |||
| Dextroamphetamine Sulfate Extended Release Capsules USP, 5, 10 & 15mg, Rx | Barr laboratories, Inc. | ANDA 76-137 | 1/18/02 | |||
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, Rx | Mutual Pharmaceutical Co. | ANDA 40-480 | 9/9/03 | |||
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, Rx | Abrika Pharmaceuticals | ANDA 40-472 | 9/30/03 | |||
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, Rx | Watson Laboratories | ANDA 40-456 | 5/6/03 | |||
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 5 mg, 10 mg, 20 mg, and 30 mg, Rx | CorePharma LLC | ANDA 40-444 | 6/19/02 | 4/9/03 | ||
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, Rx | Mallinckrodt Inc. | ANDA 40-440 | 10/7/03 | |||
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 10 mg, 20 mg, and 30 mg, Rx | Eon Labs, Inc. | ANDA 40-439 | 6/14/02 | 4/9/03 | ||
| Dextroamphetamine Sulfate Tablets USP, 5 mg & 10 mg, Rx | Mallinckrodt Inc. | ANDA 40-436 | 1/29/02 | |||
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate & Amphetamine Sulfate Tablets, 5, 10, 20 & 30 mg, Rx | Barr Laboratories, Inc. | ANDA 40-422 | 2/11/02 | |||
| Dextroamphetamine Sulfate Tablets USP, 10 mg, Rx | KV Pharmaceutical | ANDA 40-367 | 10/31/02 | |||
| Dextroamphetamine Sulfate Tablets USP, 5 mg, Rx | KV Pharmaceutical | ANDA 40-365 | 10/31/02 | |||
| Dextroamphetamine Sulfate Tablets USP, 5 mg and 10 mg. | Barr Laboratories, Inc. | ANDA 40-361 | 1/31/01 | 06/11/02 | 06/11/02 | 06/11/02 |
| Dextroamphetamine Sulfate Tablets USP, 5 mg. | Endo Pharmaceutical Inc. | ANDA 40-299 | 5/13/99 | 5/18/99 | 7/11/01 | |
| Dextrose 50% Injection in Pet Abboject Vials | Abbott Laboratories | NDA 19-445/S-004 AND S-006 | 11/24/98 | 11/30/98 | 3/5/99 | |
|
Dextrose Indications: S-004:
This supplement provides for a new sub-population - Neonates and older infants for
approved use as a minimal source of carbohydrates and calories in this population. S-006: This supplement provides for a new indication in the treatment of acute symptomatic episodes of hypoglycemia in the neonate and older infant to restore depressed blood glucose levels and control symptoms. |
||||||
| Dextrose Injection USP, Rx | B. Braun Medical Inc. | NDA 19-626/S19 | 2/13/04 | 3/3/04 | 4/5/04 | |
| Dextrose Injection USP, 10%, 20%, 30%, 40%, 50%, and 70%, Rx | Baxter Healthcare | NDA 17-521/S-062 & S-063 | 11/14/02 | 7/31/03 | ||
| Dextrose Injection USP, 10%, 20%, 30%, 40%, 50%, and 70%, Rx | Baxter Healthcare | NDA 17-521/S-061 | 12/5/00 | |||
| Dextrose Indications: Indicated as a caloric component in a parenteral nutrition program. Dextrose is safe and efftive for the stated indication in pediatric patients up to 18 years. | ||||||
| Dextrose and Potassium Chloride Injection, USP, 5%, Rx | Baxter Healthcare Corporation | NDA 17-634/S-059 | 1/3/03 | 1/23/03 | ||
| DHE 45 (dihydroergotamine) Injection & Migranal (dihydroergotamine) Nasal Spray, | Xcel Pharmaceuticals | NDA 20-148/S-007/S-008 005929/S32 & 33 |
7/31/02 | 8/6/02 | 7/31/02 | |
| Diabinese (chlorpropamide) Tablets, USP, | Pfizer Inc. | NDA 11-641/S61 | 1/4/04 | 1/9/04 | ||
| Diabinese (chlorpropamide) Tablets, USP, | Pfizer Inc. | NDA 11-641/S-058 & 11-641/S-060 | 5/16/02 | 5/21/02 | ||
| Diastat (diazepam rectal gel), Rx | Elan Pharmaceuticals, Inc. | NDA 20-648/S-002 | 4/11/01 | 4/8/03 | ||
| Diazepam Injection, 5 mg/mL, Rx | Parenta Pharmaceuticals | ANDA 76-815 | 4/15/04 | |||
| Dibenzyline (phenoxybenzamine HCl) Capsules, 10 mg, Rx | Wellspring Pharmaceutical Corporation | NDA 8-708/S23 | 12/30/03 | 1/9/04 | ||
| Dibenzyline (phenoxybenzamine HCl) Capsules, 10 mg, Rx | Wellspring Pharmaceutical Corporation | NDA 8-708/S-022 | 1/15/03 | 1/23/03 | ||
| Diclofenac Potassium Tablets, 50 mg, Rx | TorPharm, Inc. | ANDA 76-561 | 3/18/04 | |||
| Diclofenac Potassium Tablets, 50 mg, Rx | Eon Labs manufacturing, Inc. | ANDA 75-582 | 2/23/01 | 3/6/01 | ||
| Diclofenac Potassium Tablets, 50 mg, Rx | Mutual Pharmaceutical Co., Inc. | ANDA 75-470 | 2/21/02 | |||
| Diclofenac Potassium Tablets, 50 mg, Rx | Mylan Pharmaceuticals Inc. | ANDA 75-463 | 7/26/99 | 7/29/99 | ||
| Diclofenac Potassium Tablets, 50 mg, Rx | Invamed Inc. | ANDA 75-229 | 11/25/98 | 11/200/98 | ||
| Diclofenac Potassium Tablets, 50 mg, Rx | Teva Pharmaceuticals USA | ANDA 75-219 | 8/6/98 | 8/7/98 | ||
| Diclofenac Potassium Tablets, 50 mg, Rx | Watson Laboratories, Inc. | ANDA 75-152 | 11/27/98 | 12/1/98 | ||
| Diclofenac Sodium Delayed-release Tablets USP, 50 & 75 mg, Rx | Alphapharm Pty. Ltd. | ANDA 75-281 | 2/12/02 | |||
| Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg, 75 mg, Rx | Carlsbad Technology | ANDA 75-185 | 11/13/98 | 11/16/98 | ||
| Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg, 75 mg, Rx | Martec Scientific | ANDA 74-986 | 2/26/99 | 3/4/99 | 8/23/01 | |
| Diclofenac Sodium Delayed-release Tablets USP, 50 mg & 75 mg | Sidmak Laboratories | ANDA 74-432 | 7/29/99 | 8/4/99 | ||
| Diclofenac Sodium Delayed-release Tablets USP, 50 mg, Rx | Novopharm Ltd. | ANDA 74-723 | 3/30/99 | 4/1/99 | ||
| Diclofenac Sodium extended-release Tablets USP, 100 mg, Rx | Mylan Pharmaceuticals Inc. | ANDA 76-152 | 12/13/01 | |||
| Diclofenac Sodium extended-release Tablets USP, 100 mg, Rx | Purepac Pharmaceutical Co. | ANDA 75-910 | 1/7/00 | |||
| Diclofenac Sodium extended-release Tablets USP, 100 mg, Rx | Keller & Heckman | ANDA 75-492 | 2/11/00 | 2/17/00 | 6/7/01 | |
| Diclofenac Sodium Ophthalmic Solution, 0.1%, Rx | Alcon Laboratories | NDA 20-809 | 5/4/98 | 1/6/99 | 1/8/99 | 3/14/00 |
| Diclofenance Indication:treatment of postoperative inflammation in patients who have undergone cataract extraction. | ||||||
| Dicyclomine Hydrochloride Capsules USP, 10 mg | Mylan Pharmaceuticals, Inc. | ANDA 40-319 | 9/14/99 | 9/14/99 | ||
| Dicyclomine Hydrochloride Capsules USP, 20 mg | Mylan Pharmaceuticals, Inc. | ANDA 40-317 | 9/17/99 | 9/14/99 | ||
| Dicyclomine Hydrochloride Injection USP, 20 mg, Rx | Bedford Laboratories | ANDA 40-465 | 6/30/03 | |||
| Dicyclomine Hydrochloride Tablets USP, 20 mg | Lannett Company Inc. | ANDA 40-230 | 2/26/99 | 3/2/99 | 8/1/03 | |
| Didronel (Etidronate Disodium) Tablets, | Procter and Gamble Pharmaceuticals, Inc. | NDA 17-831/S53 | 2/25/04 | 2/27/04 | 4/5/04 | |
| Didronel (Etidronate Disodium) Tablets, | Procter and Gamble Pharmaceuticals, Inc. | NDA 17-831/S-052 | 3/15/02 | 3/29/02 | ||
| DIFFERIN (adapalene) Cream, 0.1%, Rx | Galderma, L.P. | NDA 20-748 | 5/26/00 | 6/6/00 | 6/6/00 | 5/8/03 |
| Diflorasone Diacetate Cream USP, 0.05% | Altana Inc. | ANDA 76-263 | 12/20/02 | |||
| Diflorasone Diacetate Cream USP, 0.05% | Altana Inc. | ANDA 75-187 | 3/30/98 | 3/5/99 | ||
| Diflorasone Diacetate Ointment USP, 0.05% | Altana Inc. | ANDA 75-374 | 4/27/99 | 5/3/99 | 12/18/01 | |
| Diflorasone Diacetate Cream USP, 0.05%, Rx | Taro Pharmaceuticals | ANDA 75-508 | 4/24/00 | 4/28/00 | ||
| Diflucan (Fluconazole) Tablets, Injection & Oral Powder, 150 mg, Rx | Pfizer, Inc. | NDA 19-949/S37, 19-950/S39 & 20-090/S19 | 3/24/04 | 3/28/04 | 4/7/04 | |
| Diflucan (Fluconazole) Tablets, Injection & Oral Powder, 150 mg, Rx | Pfizer, Inc. | NDA 19-949/S33, 19-950/S33 & 20-090/S15 | 8/7/02 | 8/12/02 | 8/9/02 | |
| Digoxin Injection USP, 0.25 mg/mL, Rx | Sabex 2002, Inc. | ANDA 40-481 | 8/21/03 | |||
| Digoxin Injection USP, 0.25 mg/mL, 2mL ampul, Rx | Abbott Laboratories | ANDA 40-206 | 8/28/98 | 9/2/98 | ||
| Digoxin Tablets USP, 0.125 mg and 0.25 mg., Rx | Caraco Pharmaceutical Laboratories | ANDA 76-393 | 1/31/03 | |||
| Digoxin Tablets USP, 0.125 mg and 0.25 mg., Rx | Jerome Stevens Pharmaceuticals, Inc. | ANDA 76-268 | 7/26/02 | 12/24/03 | ||
| Digoxin Tablets USP, 0.125 mg and 0.25 mg. | Amide Pharmaceutical, Inc. | ANDA 40-282 | 12/23/99 | 12/27/99 | 7/11/01 | |
| Dihydroergotamine Mesylate Injection, 1 mg/mL, Rx | Paddock Laboratories, Inc. | ANDA 40-475 | 4/28/03 | |||
| Dihydroergotamine Mesylate Injection, 1 mg/mL, Rx | Bedford Laboratories | ANDA 40-453 | 6/9/03 | |||
| Dilacor XR (Diltiazem Hydrochloride) Extended-Release Capsules, | Watson Laboratories | NDA 20-092/S15 | 12/12/03 | 12/16/03 | ||
| Dilantin-125 (phenytoin) Oral Suspension, Rx | Pfizer Pharmaceuticals | NDA 8-762/S-031 | 3/24/03 | 3/26/03 | ||
| Dilantin-125 (phenytoin) Oral Suspension & Dilantin (Phenytoin Sodium) Injection, USP, | Pfizer Pharmaceuticals | NDA 8-762/S-020, 021, 022 & 026 & 10-151/S-022, 029, 030, 032, 033 & 034 | 11/20/01 | 2/22/02 | ||
| Dilaudid (hydromorphone HCl, USP) Oral Liquid & Tablets, 1 mg/mL & 8 mg respectively, Rx | Abbott Laboratories | NDA 19-891/S-002 & 19-892/S-002 | 3/10/03 | 4/1/03 | ||
| Diltiazem Hydrochloride Extended-release Capsules, Rx | Biovail Laboratories Incorporated | NDA 20-939 | 1/28/00 | 2/3/00 | 2/3/00 | 2/19/02 |
| Diltiazem Indication: NDA 20-939: Hypertension Dosage | ||||||
| Diltiazem Hydrochloride Extended-release Capsules USP, 120 mg, 180 mg, 240 mg, & 300 mg., Rx | Keller and Heckman | ANDA 75-116 | 12/23/99 | 1/4/99 | ||
| Diltiazem Hydrochloride Extended-release Capsules USP, 120 mg, 180 mg, & 240 mg, Rx | Mylan Pharmaceuticals Inc. | ANDA 75-124 | 3/18/98 | 3/22/99 | ||
| Diltiazem Hydrochloride Extended-release Capsules USP, 240 mg, Rx | Torpharm | ANDA 74-943 | 8/6/98 | 8/7/98 | 8/6/03 | |
| Diltiazem Hydrochloride Extended-release Capsules USP(Once-a-Day Dosage), 120 mg, 180 mg, 240 mg and 300 mg, Rx | Purepac Pharmaceutical | ANDA 74-984 | 12/20/99 | 12/27/99 | ||
| Diltiazem Hydrochloride Extended-release Capsules USP, 60 mg, 90 mg, & 120 mg | Biovail Corp. Intl. | ANDA 74-845 | 9/15/99 | 9/24/99 | 8/22/01 | |
| Diltiazem Hydrochloride Extended-release Capsules USP, 120 mg, 180 mg, 240 mg, and 300 mg. | Andrx Pharmaceuticals | ANDA 74-752 | 7/9/98 | 8/16/00 8/16/00 |
8/16/00 | |
| Diltiazem Hydrochloride Injection, 100 mg/mL, Rx | Abbott Laboratories | ANDA 75-853 | 12/17/02 | |||
| Diltiazem Hydrochloride Injection, 5 mg/mL, Rx | International Medication Systems, Ltd | ANDA 75-749 | 11/21/01 | 4/15/03 | ||
| Diltiazem Hydrochloride Injection, 5 mg/mL, Rx | Apotex Corp. | ANDA 75-375 | 9/30/99 | 10/1/99 | ||
| Diltiazem Hydrochloride Injection, 5 mg/mL | Abbott Laboratories | NDA 74-941 | 8/15/99 | 4/23/03 | ||
| Diltiazem Hydrochloride Injection, 5 mg/mL, | Taylor Pharmaceuticals | ANDA 75-086 | 4/9/98 | 8/24/01 | ||
| Diltiazem Hydrochloride Injection, 5 mg/mL, [packed in 5 mL (25 mg), & 10 mL (50 mg) vials]. | Meridian Medical Technologies, Inc. | ANDA 75-106 | 4/29/99 | 5/4/99 | ||
| Diltiazem Hydrochloride Injection, 5 mg/mL, 5 mL Syringes, Rx | Abbott Laboratories | ANDA 75-004 | 2/16/00 | 2/24/00 | ||
| Diltiazem Hydrochloride Injection, 5 mg/mL, (25 mL Vial), Rx | Gensia Sicor Pharmaceuticals, Inc. | ANDA 74-894/S1 | 4/19/02 | |||
| Dimethyl Sulfoxide Irrigation Solution USP, 50% 50%, Rx | Bioniche Pharma Ltd. | ANDA 76-185 | 11/29/02 | |||
| Diovan Tablets, Rx | Novartis Pharmaceuticals | NDA 020818 | 3/06/98 | 8/13/03 | ||
| Diovan (valsartan) Capsules, Rx | Novartis Pharmaceuticals Corporation | NDA 20-665/S-004 | 11/27/98 |
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| Diovan (valsartan) Capsules & Tablets, Rx | Novartis Pharmaceuticals Corporation | NDA 21-283 | 7/18/01 | 5/5/03 | 8/12/03 | |
| Diovan (valsartan) Capsules & Tablets, Rx | Novartis Pharmaceuticals Corporation | NDA 20-665/S-016 & 21-283/S-001 | 8/14/02 | 8/21/02 | 8/14/02 | 2/3/03 |
| Diovan (valsartan) Tablets, Rx | Novartis Pharmaceuticals Corporation | NDA 21-283/S-002 | 4/5/02 | 4/16/02 | 7/25/02 | 7/25/02 |
| Diovan HCT (valsartan/hydrochlorothiazide) Tablets, 80/12.5 mg and 160/25 mg Rx | Novartis Pharmaceuticals Corp. | NDA 20-818/S16 | 1/15/03 | 1/23/03 | 7/8/03 | |
| Diovan HCT (valsartan/hydrochlorothiazide) Tablets, 80/12.5 mg and 160/12.5 mg. | Novartis Pharmaceuticals Corp. | NDA 20-818/S12 | 1/17/02 | 2/5/02 | ||
| Dipentum (olsalazine sodium) Capsules, | Pharmacia & Upjohn Company | NDA 19-715/S-021 | 8/9/02 | 8/12/02 | ||
| Dipentum (olsalazine sodium) Capsules. | Pharmacia & Upjohn Company | NDA 19-715/S-018 | 1/18/02 | 2/5/02 | ||
| Diphenhydramine Hydrochloride Injection USP, (Preservative-Free), 50 mg/ml | American Pharmaceutical Partners, Inc. | ANDA 40-466 | 5/28/02 | 4/9/03 | ||
| Diphenhydramine Hydrochloride Injection USP, (Preservative-Free), 50 mg/ml | Abbott Laboratories | ANDA 40-140 | 11/20/98 | 11/20/98 | ||
| Diphenoxylate Hydrochloride & Atropine Sulfate Tablets,2.5 mg/0.025, Rx | Able Laboratories, Inc. | ANDA 40-395 | 11/27/00 | 11/27/00 | ||
| Diphenoxylate Hydrochloride & Atropine Sulfate Tablets,2.5 mg/0.025, Rx | Par Pharmaceuticals | ANDA 40-357 | 5/2/00 | |||
| Diprivan (propofol) Injectable Emulsion,10 mg/mL, Rx | AstraZeneca LP | NDA 19-627/S-35 | 2/23/01 | 3/14/01 | 3/14/01 | |
| Diprolene AF (Betamethasone Dipropionate) Cream, 0.05%, Rx | Schering Corporation | NDA 19-555/S8 & S16 | 10/3/01 | 11/6/01 | 11/6/01 | 11/14/01 |
| Diprosone AF (Betamethasone Dipropionate) Cream, 0.05%, Rx | Schering Corporation | NDA 17-536/S16 & S8 | 10/3/01 | |||
| Diprosone (Betamethasone Dipropionate) Cream, 0.05%, Rx | Schering Corporation | NDA 17-536/S24 & S18 | 10/3/01 | 11/5/01 | 11/5/01 | 11/14/01 |
| Diprosone (Betamethasone Dipropionate) Lotion, 0.05%, Rx | Schering Corporation | NDA 17-781/S22 & S15 | 10/3/01 | 11/6/01 | 11/6/01 | 11/14/01 |
| Diprosone (Betamethasone Dipropionate) Ointment, 0.05%, Rx | Schering Corporation | NDA 17-691/S19 & S24 | 10/3/01 | 11/5/01 | 11/5/01 | 11/14/01 |
| Dipyridamole Injection, 5 mg/mL, Rx | Apotex Corp. | ANDA 75-769 | 11/27/02 | |||
| Dipyridamole Single-Dose Vials, 5 mg/mL, 2 mL and 10 mL, Rx | American Pharmaceutical Partners | ANDA 74-956 | 9/30/98 | 9/30/98 | 9/25/02 | |
| DisperMox (Amoxicillin) Tablets for Oral Suspension, Rx | Ranbaxy | ANDA 65-080 | 8/11/03 | <|||