|
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 |
|---|---|---|---|---|---|---|
| Econazole Nitrate Cream, 1%, Rx | Altana Inc. | ANDA 76-075 | 11/26/02 | 4/13/04 | 4/13/04 | 4/13/04 |
| Econazole Nitrate Cream, 1%, Rx | Taro Pharmaceuticals | ANDA 76-005 | 11/26/02 | 12/24/03 | ||
| Econopred & Econopred Plus (prednisolone acetate ophthalmic suspension), 1/8% and 1% respectively, Rx | Alcon Laboratories, Inc. | NDA 17-468/S-019 & 17-469/S-031 | 4/17/03 | 7/31/03 | ||
| Edecrin (Ethacrynic Acid) Tablets & (Ethacrynate Sodium) Injection, | Merck & Co., Inc. | NDA 16-092/S39 & 16-093/S43 | 1/3/04 | 3/3/04 | ||
| Edecrin (Ethacrynic Acid) Tablets & Edecrin (Ethacrynate Sodium) Injection | Merck & Co., Inc. | NDA 16-092/S037 & 16-093/S038 | 10/19/99 | 6/20/01 | ||
| Edetate Disodium Injection USP, 150 mg/mL, Rx | Bioniche Pharma Ltd. | ANDA 40-437 | 7/9/02 | 4/9/03 | ||
| Edetate Disodium Injection USP, 150 mg/mL, Rx | Apotex Corp. | ANDA 40-376 | 11/4/02 | |||
| Effexor & Effexor XR (Venlafaxine Hydrochloride) Immediate & Extended Release Tablets & Capsules, Rx | Wyeth Pharmaceuticals | NDA 20-151/S29, 20-699/S46 | 4/8/04 | |||
| Effexor & Effexor XR (Venlafaxine Hydrochloride) Immediate & Extended Release Tablets & Capsules, Rx | Wyeth Pharmaceuticals | NDA 20-151/S27, 20-699/S39, & S50 | 3/19/04 | 3/23/04 | ||
| Effexor & Effexor XR (Venlafaxine Hydrochloride) Immediate & Extended Release Capsules, Rx | Wyeth-Ayerst | NDA 20-151/S16, S19, S20, S21, S22, S23, S25 & 20-699/S14, S18, S21, S23, S26, S27, S34 | 1/31/03 | 2/12/03 | ||
| Effexor XR (venlafaxine hydrochloride) Extended Release Capsules, 37.5 mg, 75 mg, and 150 mg, Rx | Wyeth-Ayerst | NDA 20-699/S-015, S016, 20-151/S017, S018 | 5/2/01 | 7/30/03 | 4/25/03 | |
| Effexor XR (venlafaxine hydrochloride) Extended Release Capsules, Rx | Wyeth Pharmaceuticals | NDA 20-699/S45 | 3/16/04 | 3/17/04 | ||
| Effexor XR (venlafaxine hydrochloride) Extended Release Capsules, 37.5 mg, 75 mg, and 150 mg, Rx | Wyeth-Ayerst | NDA 20-699/S-032 | 2/26/03 | 3/10/03 | ||
| Effexor, Rx | Wyeth-Ayerst | NDA 20-151/S17 & S18 | 5/2/01 | 4/23/03 | ||
| Effexor XR, Rx | Wyeth-Ayerst | NDA 20-151/S15 & S16 | 5/2/01 | |||
| Effexor Indications: Prevention o relapse and recurrence of depression. | ||||||
| Effexor XR (venlafaxine hydrochloride) Extended Release Capsules, Rx | Wyeth-Ayerst | NDA 20-699/S-022 | 2/11/03 | 2/12/03 | 2/13/03 | |
| Effexor XR (venlafaxine hydrochloride) Extended Release Capsules, Rx | Wyeth-Ayerst | NDA 20-699/S-029 | 10/22/02 | 10/28/02 | ||
| Effexor XR (venlafaxine hydrochloride) Extended Release Capsules. | Wyeth-Ayerst Research | NDA 20-699/S-001 | 3/11/99 | 3/22/99 | 3/22/99 | |
| Effexor XR (venlafaxine hydrochloride) Extended Release Capsules. | Wyeth-Ayerst Research | NDA 20-699/S-038 & S-043 | 9/2/03 | 9/9/03 | ||
| Efudex (fluorouracil) Topical Solution, 5% | ICN Pharmaceuticals | NDA 16-831/S46 | 4/27/04 | |||
| Elavil (amitriptyline hydrochloride) Tablets & Injection, | AstraZeneca Pharmaceuticals | NDA 12-703/S-093 & 12-704/S-046 | 7/29/03 | 8/6/03 | ||
| Elavil (amitriptyline hydrochloride) Tablets (NDA 12-703) and Injection (NDA 12-704). | AstraZeneca Pharmaceuticals | NDA 12-704/S-045 & 12-703/S-092 | 3/27/01 | 5/1/01 | ||
| Elestat (Epinastine HCI) Ophthalmic Solution, 0.05% | Allergan, Inc. | NDA 21-565 | 10/16/03 | 10/17/03 | 10/17/03 | 12/30/03 |
| Elidel (Pimecorlimus) Cream, 1%, Rx | Novartis Pharmaceuticals Corporation | NDA 21-302/S4 | 10/15/03 | 10/17/03 | 10/17/03 | |
| Elidel (Pimecorlimus) Cream, 1%, Rx | Novartis Pharmaceuticals Corporation | NDA 21-302 | 12/13/01 | 2/28/02 | 2/28/02 | 2/28/02 |
| Eligard (Leuprolide Acetate) Injection, 7.5, 22.5 & 30 mg, respectively, Rx | Sanofi-Synthelabo | NDA 21-488/S2, 21-379/S2 & 21-343/S4 | 1/12/04 | 1/14/04 | ||
| Eligard (Leuprolide Acetate) Injection, 30 mg, Rx | Atrix Laboratories, Inc. | NDA 21-488 | 2/13/03 | 2/25/03 | 2/14/03 | 5/8/03 |
| Eligard (Leuprolide Acetate) Injection, 22.5 mg, Rx | Atrix Laboratories, Inc. | NDA 21-379 | 7/24/02 | 8/6/02 | 7/24/02 | 10/22/02 |
| Eligard (Leuprolide Acetate) Injection, Rx | Atrix Laboratories, Inc. | NDA 21-343/S2 | 7/3/03 | 7/8/03 | ||
| Eligard (Leuprolide Acetate) Injection, 7.5 mg, Rx | Sanofi-Sythelabo Inc. | NDA 21-343/S-1 | 4/1/02 | 4/8/02 | ||
| Eligard (Leuprolide Acetate) Injection, 7.5 mg, Rx | Atrix Laboratories, Inc. | NDA 21-343 | 1/23/02 | 1/31/02 | 1/31/02 | 2/12/02 |
| Eligard Indications: Palliative treatment of advanced prostate cancer. | ||||||
| Ellence (epirubicin hydrochloride) Injection, 50 mg/25 mL & 200 mg/100 mL single-use vials, Rx | Pharmacia & Upjohn | NDA 50-778/S3 & S4 | 4/3/03 | 4/18/03 | ||
| Ellence (epirubicin hydrochloride), 50 mg/25 mL & 200 mg/100 mL single-use vials; Intravenous, Rx | Pharmacia & Upjohn | NDA 50-778 | 9/15/99 | 9/24/99 | 9/24/99 | 1/30/03 |
| Ellence Indication: Indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer. | ||||||
| ELOCON (mometasone furoate) Cream, 0.1%, | Schering Corporation | NDA 19-625/S-012 & S-013 | 7/17/02 | 7/24/02 | 7/19/02 | |
| ELOCON (mometasone furoate) Lotion, 0.1%, | Schering Corporation | NDA 19-796/S-08 & S-015 | 7/17/02 | 7/24/02 | 7/19/02 | |
| ELOCON (mometasone furoate) Ointment, 0.1%, Rx | Schering Corporation | NDA 19-543/S-014 | 12/15/02 | 1/23/03 | 12/16/02 | |
| ELOCON (mometasone furoate) Ointment, 0.1%, | Schering Corporation | NDA 19-543/S-011 & S-013 | 7/17/02 | 7/24/02 | 7/19/02 | |
| Eloxatin (oxaliplatin) Injection, Rx | Sanofi-Synthelabo, Inc. | NDA 21-492/S2 | 1/9/04 | 1/12/04 | 1/15/04 | |
| Eloxatin (oxaliplatin) for Injection, Rx | Sanofi-Synthelabo, Inc. | NDA 21-492/S1 | 1/14/03 | 1/23/03 | ||
| Eloxatin (oxaliplatin) for Injection, Rx | Sanofi-Synthelabo, Inc. | NDA 21-492 | 8/9/02 | 8/12/02 | 8/12/02 | 10/22/02 |
| Emadine (emedastine difumarate ophthalmic solution), 0.05%, Rx | Alcon Laboratories, Inc. | NDA 20-706/S-011 | 5/12/03 | |||
| Embeline E Emollient Cream (Clobetasol Propionate Cream, [Emollient]),0.05% | Healthpoint, Ltd. | ANDA 75-325 | 12/24/98 | 12/24/98 | ||
| Embeline Gel, 0.05% (Clobetasol Propionate Gel, 0.05%, Rx | Healthpoint, Ltd. | ANDA 76-141 | 4/12/02 | 4/10/03 | ||
| Emcyt (estramustine phosphate sodium) Capsules, | Pfizer | NDA 18-045/S21 | 10/28/03 | 10/31/03 | 10/31/03 | |
| Emcyt (estramustine phosphate sodium) Capsules | Pharmacia and Upjohn | NDA 18-045/S-016 | 1/18/02 | 2/5/02 | ||
| EMEND (Aprepitant) Capsules, Rx | Merck & Company, Inc. | NDA 21-549/S2 | 1/15/04 | 1/22/04 | ||
| EMLA Anesthetic Disc (Lidocaine 2.5% & Prilocaine 2.5%), Rx | Astra, USA, Inc. | NDA 20-962 | 2/4/98 | 7/8/99 | ||
| EMLA Anesthetic Disc, Rx | AstraZeneca LP | NDA 19-941/S14, S15 | 1/27/03 | 1/29/03 | ||
| EMLA Cream (Lidocaine 2.5% & Prilocaine 2.5%), Rx | Astra, USA, Inc. | NDA 19-941/S-010 | 3/11/99 | 4/8/99 | ||
| EMLA Cream (Lidocaine 2.5% & Prilocaine 2.5%), Rx | Astra, USA, Inc. | NDA 19-941/S-008 | 2/4/98 | 7/27/99 | ||
| EMLA Cream (Lidocaine & Prilocaine), Rx | AstraZeneca | NDA 19-941/S011 | 1/28/00 | 2/14/00 | 2/14/00 | 3/24/04 |
| EMLA (S-11) Indication:Topical anesthetic for superficial minor surgery of genital mucous membranes and as an adjunct for local infiltration anesthesia in genital mucous membranes. | ||||||
| Emtriva (emtricitabine) Capsules, 200 mg | Gilead Sciences, Inc. | NDA 21-500 | 7/2/03 | 7/8/03 | 7/8/03 | 9/9/03 |
| Enalapril Maleate and Hydrochlorothiazide Tablets USP, 5 mg/12.5 mg and 10 mg/25 mg, Rx | Eon Labs Manufacturing, Inc. | ANDA 76-116 | 9/19/01 | |||
| Enalapril Maleate and Hydrochlorothiazide Tablets USP, 5 mg/12.5 mg and 10 mg/25 mg, Rx | Dr. Reddy's Laboratories Limited | ANDA 75-909 | 10/15/01 | 4/17/03 | 1/17/02 | |
| Enalapril Maleate and Hydrochlorothiazide Tablets USP, 5 mg/12.5 mg and 10 mg/25 mg, Rx | Taro Pharmaceuticals Industries Ltd. | ANDA 75-788 | 9/18/01 | 4/15/03 | ||
| Enalapril Maleate and Hydrochlorothiazide Tablets USP, 5 mg/12.5 mg and 10 mg/25 mg, Rx Tentatively Approved | Taro Pharmaceuticals | ANDA 75-788 | 4/18/01 | 4/24/01 | ||
| Enalapril Maleate and Hydrochlorothiazide Tablets USP, 5 mg/12.5 mg and 10 mg/25 mg, Rx | IVAX Pharmaceuticals | ANDA 75-736 | 3/25/03 | |||
| Enalapril Maleate and Hydrochlorothiazide Tablets USP, 5 mg/12.5 mg and 10 mg/25 mg, Rx | Teva Pharmaceuticals | ANDA 75-727 | 9/18/01 | 4/14/03 | ||
| Enalapril Maleate and Hydrochlorothiazide Tablets USP, 5 mg/12.5 mg and 10 mg/25 mg, Rx Tentatively Approved | Teva Pharmaceuticals | ANDA 75-727 | 6/8/01 | 6/26/01 | ||
| Enalapril and Hydrochlorothiazide Tablets USP, 5 mg/12.5 mg and 10 mg/25 mg, Rx | Mylan Pharmaceuticals, Inc. | ANDA 75-624 | 9/18/01 | 4/14/03 | ||
| Enalapril and Hydrochlorothiazide Tablets USP, 5 mg/12.5 mg and 10 mg/25 mg, Rx Tentatively Approved 2/22/2000 | Mylan Pharmaceuticals, Inc. | ANDA 75-624 | 2/22/00 | 2/24/00 | ||
| Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, Rx | Taro Pharmaceutical | ANDA 75-657 | 1/23/01 | 3/5/01 | ||
| Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, Rx | Eon Labs Manufacturing, Inc. | ANDA 75-621 | 8/22/00 | 11/7/00 | ||
| Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, Rx Tentatively Approved 6/29/2000 | Eon Labs Manufacturing, Inc. | ANDA 75-621 | 6/29/00 | 11/7/00 | ||
| Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, Rx | Apothecon Inc., A Bristol-Myers Squibb Co. | ANDA 75-583 | 8/22/00 | |||
| Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, Rx Tentatively Approved 3/29/2000 | Apothecon Inc., A Bristol-Myers Squibb Co. | ANDA 75-583 | 3/29/00 | 3/31/00 | ||
| Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, Rx | Ranbaxy Laboratories Ltd. | ANDA 75-556 | 8/22/00 | 11/6/00 | ||
| Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, Rx Tentatively Approved 4/17/2000 | Ranbaxy Laboratories Ltd. | ANDA 75-556 | 4/17/00 | 4/24/00 | ||
| Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg, & 20 mg, Rx | Chelsea Laboratories, Inc. | ANDA 75-501 | 8/22/00 | 11/6/00 | ||
| Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg, & 20 mg, Rx Tentatively Approved 5/19/2000 | Chelsea Laboratories, Inc. | ANDA 75-501 | 5/19/00 | 5/22/00 | ||
| Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, Rx | Lek Pharmaceutical & Chemical Company d.d. | ANDA 75-496 | 8/22/00 | |||
| Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, Rx | Wockhardt Americas Inc. | ANDA 75-483 | 8/22/00 | 11/6/00 | ||
| Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, Rx | Zenith Goldline Pharmaceuticals Inc. | ANDA 75-482 | 8/22/00 | 11/6/00 | ||
|
Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20
mg, Rx Tentatively Approved 2/22/00 |
Zenith Goldline Pharmaceuticals Inc. | ANDA 75-482 | 2/22/00 | 2/24/00 | ||
| Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, Rx | Mylan Pharmaceuticals Inc. | ANDA 75-480 | 8/22/00 | 11/6/00 | ||
| Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, Rx Tentatively Approved 2/18/2000 | Mylan Pharmaceuticals Inc. | ANDA 75-480 | 2/18/00 | 2/24/00 | ||
| Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, Rx | Teva Pharmaceuticals | ANDA 75-479 | 8/22/00 | 11/6/00 | ||
| Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, Rx Tentatively Approved 6/29/2000 | Teva Pharmaceuticals | ANDA 75-479 | 4/12/00 | 4/17/00 | ||
| Enalapril Maleate Tablets USP, 2.5 mg and 5 mg/10 mg and 20 mg., Rx | Par Pharmaceuticals Inc. | ANDA 75-472 | 8/22/00 | 11/6/00 | ||
| Enalapril Maleate Tablets USP, 2.5 mg and 5 mg/10 mg and 20 mg., Rx Tentatively Approved 3/28/00 | Genpharm Inc. | ANDA 75-472 | 6/29/00 | 11/6/00 | ||
| Enalapril Maleate Tablets USP, 10 mg and 20 mg, Rx | Lek Pharmaceutical & Chemical Company d.d. | ANDA 75-459 / 75-496 | 8/22/00 | 11/6/00 | ||
| Enalapril Maleate Tablets USP, 2.5 mg and 5 mg/10 mg and 20 mg, Rx | Danbury Pharmacal, Inc. | ANDA 75-370 / 75-369 | 8/22/00 | 10/30/00 | ||
| Enalapril Maleate Tablets USP, 2.5 mg and 5 mg/10 mg and 20 mg., Rx Tentatively Approved 3/28/00 | Danbury Pharmacal, Inc. | ANDA 75-370 / 75-369 | 3/28/00 | 4/4/00 | ||
| Enalapril Maleate Tablets USP, 2.5 mg and 5 mg/10 mg and 20 mg., Rx Tentatively Approved Jan. 29, 1999 | Danbury Pharmacal, Inc. | ANDA 75-370 / 75-369 | 1/29/99 | 2/5/99 2/5/99 | ||
|
Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20
mg, Rx Tentatively Approved 3/20/2000 |
ESI Lederle, Inc. | ANDA 75-277 | 3/20/00 | 3/31/00 | ||
|
Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20
mg, Rx Tentatively Approved 3/29/1999 |
ESI Lederle, Inc. | ANDA 75-277 | 3/29/99 | 3/30/99 | ||
| Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, Rx | Geneva | ANDA 75-048 | 8/22/00 | 10/31/00 | ||
|
Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20
mg, Rx Tentatively Approved 3/5/1999 |
Geneva | ANDA 75-048 | 3/5/99 | 8/18/00 | ||
| Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, Rx | Torpharm | ANDA 75-178 | 3/23/01 | 3/30/01 | ||
|
Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20
mg, Rx Tentatively Approved 5/28/1999 |
Apotex Corporation | ANDA 75-178 | 5/28/99 | 6/1/99 | ||
Enalaprilat Injection , 1.25 mg/mL, Rx |
Bedford Laboratories | ANDA 75-634 | 8/22/00 | 11/7/00 | ||
Enalaprilat Injection
, 1.25 mg/mL, Rx
|
Bedford Laboratories | ANDA 75-634 | 5/25/00 | 6/6/00 | ||
Enalaprilat Injection , 1.25 mg/mL, Rx |
Gensia Sicor Pharmaceuticals, Inc. | ANDA 75-578 | 8/22/00 | 11/7/00 | ||
Enalaprilat Injection
, 1.25 mg/mL, Rx
|
Gensia Sicor Pharmaceuticals, Inc. | ANDA 75-578 | 4/18/00 | 5/1/00 | ||
Enalaprilat Injection , 1.25 mg/mL, Rx |
Faulding Pharmaceutical Co. | ANDA 75-571 | 8/22/00 | 11/7/00 | ||
Enalaprilat Injection
, 1.25 mg/mL, Rx
|
Faulding Pharmaceutical Co. | ANDA 75-571 | 1/28/00 | 2/4/00 | ||
| Enalaprilat Injection, 1.25 mg/mL, Rx | Abbott Laboratories | ANDA 75-456 ANDA 75-458 |
8/22/00 | 11/6/00 | 12/6/01 | |
|
Enalaprilat Injection, 1.25 mg/mL, Rx Tentatively Approved |
Abbott Laboratories | ANDA 75-456 ANDA 75-458 |
10/29/99 | 12/29/99 | ||
| Enbrel Etanercept | Immunex Corporation | BLA 103795 / 5123 | 7/24/03 | 11/5/03 | ||
| Enbrel Etanercept | Immunex Corporation | BLA 103795 / 5110 | 10/17/03 | 11/5/03 | ||
| Enbrel Etanercept | Immunex Corporation | BLA 103795 / 5102 | 8/21/03 | 11/5/03 | ||
| Enbrel Etanercept | Immunex Corporation | BLA 103795 / 5097 | 10/9/03 | 11/5/03 | ||
| Enbrel Etanercept | Immunex Corporation | BLA 103795 / 5097 | 7/24/03 | 11/5/03 | ||
| Enbrel Etanercept | Immunex Corporation | BLA 103795 / 5055 | 7/24/03 | 11/5/03 | ||
| Enpresse-21 Tablets & Enpresse-28 Tablets, Rx | Duramed Pharmaceuticals, Inc. | ANDA 75-809 | 7/16/01 | |||
| Entocort EC (Budesonide) Capsules, 3 mg, Rx | AstraZeneca LP | NDA 21-324/S4 | 3/13/03 | 3/26/03 | ||
| Entocort EC (Budesonide) Capsules, 3 mg, Rx | AstraZeneca LP | NDA 21-324/S3 | 10/3/02 | 10/11/01 | ||
| Entocort EC (Budesonide) Capsules, Rx | AstraZeneca LP | NDA 21-324/S1 | 8/9/02 | 8/30/02 | ||
| Entocort EC (Budesonide) Capsules, Rx | AstraZeneca LP | NDA 21-324 | 10/2/01 | 1/28/02 | 1/28/02 | 1/28/02 |
| Entocort Indications: Treatment of mild to moderate active Crohn's Disease involving the ileum and/or ascending colon. | ||||||
| Epipen & Epipen Jr. (Epinephrine) Injection, | Meridian Technologies | NDA 19-430/S25 | 12/22/03 | |||
| Epipen 0.3 mg Epinephrine auto-injector | Meridian Technologies | NDA 19-430/S12 | 4/15/03 | |||
| Epivir (lamivudine), Tablets and Oral solution, Rx | GlaxoSmithKline | NDA 20-564/S19 & 20-596/S20 | 11/13/03 | 11/25/03 | 12/2/03 | |
| Epivir (lamivudine), Tablets and Oral solution, 150mg, Rx | GlaxoSmithKline | NDA 20-564/S-016 & 20-596/S-017 | 3/1/02 | 3/5/02 | ||
| Epivir (lamivudine), Tablets and Oral solution, 150mg, Rx | GlaxoSmithKline | NDA 20-564/S-015 & 20-596/S-016 | 6/24/02 | 7/2/02 | 6/25/02 | |
| Epivir (lamivudine), Tablets and Oral solution, 150mg, Rx | GlaxoSmithKline | NDA 20-564/S-014 & 20-596/S-015 | 10/8/02 | 10/11/01 | 10/8/02 | |
| Epivir (lamivudine), Tablets and Oral solution, 150mg, Rx | GlaxoSmithKline | NDA 20-564/S-012 & 20-596/S-013 | 3/6/01 | 4/26/01 | ||
| Epivir-HBV (Lamivudine) Tablets & Oral Solution, Rx | GlaxoSmithKline | NDA 21-003/S4 & 21-004/S5 | 11/13/03 | 11/25/03 | 12/1/03 | |
| Epivir-HBV (Lamivudine) Tablets & Oral Solution, 100 mg & 5 mg/mL, Rx | GlaxoSmithKline | NDA 21-003/S2 & 21-004/S2 | 8/16/01 | 11/6/01 | 11/6/01 | 11/26/01 |
| Epivir-HBV (lamivudine) Tablets and Oral Solution | Glaxo Wellcome | NDA 21-003 & 21-004 | 12/8/98 | 9/7/01 | ||
| Equagesic (meprobamate with aspirin) Tablets, | Women First HealthCare | NDA 11-702/S-036 | 5/19/03 | |||
| Erbitux (cetuximab),
Rx More Information |
ImClone | BLA 125084 | 2/12/04 | 4/8/04 | 2/12/04 | |
| Errin (Norethindrone) Tablets, 0.35 mg, Rx | Barr Laboratories, Inc. | ANDA 76-225 | 10/21/02 | |||
| Ertaczo (Sertaconazole Nitrate) Cream, 2%, Rx | Mylan Pharmaceuticals | NDA 21-385 | 12/10/03 | 12/16/03 | 12/10/03 | 3/8/04 |
| Eryc (Erythromycin) Delayed-Release Capsules, | F. H. Faulding & Co. | NDA 50-536/S18 | 12/18/03 | 12/22/03 | ||
| Eryc (Erythromycin) Delayed-Release Capsules, | F. H. Faulding & Co. | NDA 50-536/S16 | 1/2/04 | 2/27/04 | ||
| E. E. S. Granules, EryPed® Drops, Ery Ped ® 200 and EryPed® 400 (erythromycin ethylsuccinate) oral suspension, USP, EryPed ® (erytrhomycin ethylsuccinate) Chewable Tablets & PCE (erythormycin particles in tablets) Tablets, | Abbott Laboratories | NDA 50-207/S61, 50-297/S24 & 50-611/S24 | 3/12/04 | 3/16/04 | ||
| E. E. S. Granules, EryPed® Drops, Ery Ped ® 200 and EryPed® 400 (erythromycin ethylsuccinate) oral suspension, USP, EryPed ® (erytrhomycin ethylsuccinate) Chewable Tablets & PCE (erythormycin particles in tablets) Tablets, | Abbott Laboratories | NDA 50-207/S-057, 50-297/S-019 & 50-611/S-019 | 4/25/02 | 5/2/02 | ||
| Erythrocin® Piggyback (sterile erythromycin lactobionate), and Erythrocin Lactobionate-IV (sterile erythromycin lactobionate), Rx | Abbott Laboratories | NDA 50-182/S-122 & 50-609/S-015 | 5/23/02 | 6/3/02 | ||
| Erythromycin Topical Gel USP, 2%, Rx | Glades Pharmaceuticals, Inc. | ANDA 65-009 | 3/18/02 | 10/10/02 | ||
| Erythromycin & Benzoyl Topical Gel USP, 3% & 5%, Rx | Atrix Pharmaceuticals, Inc. | ANDA 65-112 | 3/29/04 | |||
| Esclim (Estradiol) Transdermal System, 0.025, 0.0375, 0.05, 0.075, and 0.1 mg/24 hrs. | Fournier Research | NDA 20-847 | 8/3/98 | 8/5/98 | 8/5/98 8/5/98 |
1/21/99 |
| Eskalith (lithium carbonate) Capsules, Tablets & CR Tablets, | GlaxoSmithKline | NDA 16-860/S74, 17-971/S20 & 18-152/S20 | 3/11/04 | 3/16/04 | 4/7/04 | |
| Eskalith (lithium carbonate) Capsules and Eskalith CR (lithium carbonate) Controlled Release Tablets, | SmithKline Beecham Corporation | NDA 16-860/S-073, 17-971/S-019 & 18-152/S-017 | 8/5/02 | 8/6/02 | ||
| Esmolol Hydrochloride Concentrate, 250 mg/mL, Rx Tentatively Approved | PharmaForce | ANDA 76-456 | 6/26/03 | |||
| Esmolol Hydrochloride Concentrate, 250 mg/mL, Rx Tentatively Approved | Bedford Laboratories | ANDA 76-326 | 6/26/03 | |||
| Esmolol Hydrochloride Injection, 10 mg/mL, Rx Tentatively Approved | PharmaForce, Inc. | ANDA 76-474 | 6/26/03 | |||
| Esmolol Hydrochloride Injection, 10 mg/mL, Rx Tentatively Approved | Bedford Laboratories | ANDA 76-323 | 6/26/03 | |||
| Estradiol Tablets USP, 0.5 mg, 1 mg and 2mg, Rx | USL Pharma, Inc. | ANDA 40-297 | 4/17/02 | 4/8/03 | ||
| Estradiol Tablets USP, 0.5 mg, 1 mg and 2mg, Rx | ESI Lederle, Inc. | ANDA 40-275 | 12/29/98 | 12/29/98 | 8/4/03 | |
| Estradiol Tablets, 0.5 mg, 1 mg and 2mg, Rx | Endeavor Pharmaceuticals | ANDA 40-138 | 1/30/98 | 3/19/98 | ||
| Estradiol Tablets, 0.5 mg, 1 mg and 2mg, Rx | Mylan Pharmaceuticals | ANDA 40-326 | 4/21/99 | 4/27/99 | 8/4/03 | |
| Estradiol Transdermal System, Rx | Menorest Manufacturing, Inc. | NDA 20-538/S-006 | 1/8/99 | 6/22/99 | ||
| Estradiol Transdermal System,0.1 mg/day, Rx | Mylan Technologies, Inc. | ANDA 75-182 | 2/24/00 | 2/24/00 | 6/7/01 | |
| Estradiol Transdermal System,0.05 mg/day, Rx | Mylan Technologies, Inc. | ANDA 75-233 | 2/24/00 | 2/24/00 | 6/7/01 | |
| Estrasorb (Estradiol) Topical Emulsion, | Novavax | NDA 21-371 | 10/9/03 | 10/16/03 | 10/16/03 | |
| ESTRATAB (Esterified Estrogens Tablets) | Solvay Pharmaceuticals, Inc. | ANDA 86-715/S-030 & ANDA 83-209/S-054 | 3/10/98 |
|
2/4/99 | |
| Estrogel (Estradiol) Gel, | Solvay Pharmaceuticals | NDA 21-166 | 2/9/04 | 3/3/04 | 4/5/04 | |
| Estropipate Tablets USP,0.75 mg, 1.5 mg, & 3 mg | Duramed | ANDA 40-296 | 11/1/99 | 12/30/99 | ||
| Estropipate Tablets USP,0.75 mg, 1.5 mg, & 3 mg | Mylan Phrmaceuticals, Inc. | ANDA 40-359 | 8/26/99 | 9/2/99 | ||
| Estrostep (Norethindrone Acetate & Ethinyl Estradiol) Tablets, Rx | Parke-Davis Pharmaceutical Research | NDA 21-276 | 7/13/01 | 11/6/01 | 11/6/01 | 12/12/01 |
| Estrostep (Norethindrone Acetate/ Ethinyl Estradiol) Tablets, Rx | Parke-Davis Pharmaceutical Research | NDA 20-130/S07 | 7/01/01 | 4/25/03 | ||
| Estrostep (Norethindrone Acetate/ Ethinyl Estradiol) Tablets, Rx | Pfizer, Inc. | NDA 20-130/S009 | 6/14/02 | 6/17/02 | ||
| Estrostep (Norethindrone Acetate & Ethinyl Estradiol) Tablets, Rx | Parke-Davis Pharmaceutical Research | NDA 20-130/S003 | 5/7/99 | 7/3/01 | ||
| Ethambutol Hydrochloride Tablets USP, 400 mg, Rx | Barr Laboartories, Inc. | ANDA 76-057 | 11/26/01 | 4/16/03 | ||
| Ethambutol Hydrochloride Tablets USP, 100 mg and 400 mg. | West-ward Pharmaceutical Corp. | ANDA 75-095 | 11/30/99 | 12/28/99 | ||
| Ethamolin (ethanolamine oleate) Injection, 50 mg/mL | Questcor Pharmaceuticals, Inc. | NDA 19-357/S-014 | 2/5/02 | 4/17/02 | ||
| Ethosuximide Capsules, 250 mg, Rx | Banner Pharmacaps Inc. | ANDA 40-430 | 10/28/02 | |||
| Ethosuximide Syrup, 250 mg/5 mL, Rx | Mikart, Inc. | ANDA 40-506 | 12/22/03 | |||
| Ethosuximide Syrup,250 mg/5 mL, Rx | Pharmaceutical Associates, Inc. | ANDA 40-253 | 11/22/00 | 11/27/00 | 8/1/03 | |
| Ethrane (enflurane USP) Liquid for Inhalation, | Baxter Healthcare Corporation | NDA 17-087/SLR-045 | 10/8/02 | 10/10/02 | ||
| Etidronate Disodium Tablets USP, 200 & 400 mg, Rx | Genpharm Inc. | ANDA 75-800 | 1/24/03 | |||
| ETHYOL (amifostine) Injection, Rx | MedImmune Oncology, Inc. | NDA 20-221/S-017 | 3/27/03 | 4/15/03 | 4/1/03 | |
| ETHYOL (amifostine) Injection, Rx | MedImmune Oncology, Inc. | NDA 20-221/S-015 | 2/20/02 | 2/21/02 | ||
| ETHYOL (amifostine) Injection, 500mg (amifostine anhydrous base), Rx | US Bioscience | NDA 20-221/S-012 | 6/24/99 | 6/25/99 | 6/25/99 | 6/22/01 |
| Ethyol Indication: To reduce the incidence of moderate to severe xerostomia in patients undergoing post-ooperative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands (see Clinical Studies). | ||||||
| Etodolac Capsules, 200 mg & 300 mg. | Torpharm | ANDA 75-419 | 7/28/00 | 10/30/00 | ||
| Etodolac Capsules, 200 mg & 300 mg. | Novopharm NC, Inc. | ANDA 75-126 | 9/16/99 | 9/24/99 | ||
| Etodolac Capsules, 200 mg & 300 mg. | Taro Pharmaceuticals, USA, Inc. | ANDA 75-078 | 4/30/98 | 3/19/99 | ||
| Etodolac Capsules, 200 mg and 300 mg, Rx | Genpharm | ANDA 75-071 | 9/30 | 9/30 | ||
| Etodolac Capsules, 300 mg. | Aesgen Inc. | ANDA 74-929 | 1/30/98 | 3/19/99 | ||
| Etodolac Extended-Release Tablets, 400, 500 & 600 mg, Rx | Taro Pharmaceutical Industries | ANDA 76-174 | 3/13/03 | |||
| Etodolac Extended-Release Tablets, 400, 500 & 600 mg, Rx | Eon Labs, Inc. | ANDA 75-943 | 7/26/02 | |||
| Etodolac Extended-Release Tablets, 500 mg, Rx | Andrx | ANDA 75-829 | 11/30/01 | 4/15/03 | ||
| Etodolac Extended-Release Tablets, 400 mg, Rx | Whitney Pharmaceuticals, Inc. | ANDA 75-696 | 7/31/00 | 11/7/00 | ||
| Etodolac Extended-Release Tablets, 400 mg, 500 mg and 600 mg, Rx | Teva Pharmaceuticals | ANDA 75-665/S-1,2,3 | 2/5/01 | 3/5/01 | ||
| Etodolac Extended-Release Tablets, 400 mg, 500 mg and 600 mg, Rx Tentatively Approved 7/31/00 | Teva Pharmaceuticals | ANDA 75-665 | 7/31/00 | 11/7/00 | ||
| Etodolac Tablets, 400 mg and 500 mg, Rx | Apotex Corp. | ANDA 76-004 | 12/3/02 | |||
| Etodolac Tablets, 400 mg and 500 mg | Ranbaxy Pharmaceuticals, Inc. | ANDA 75-226 | 11/24/98 | 11/24/98 | ||
| Etodolac Tablets, 400 mg. | Taro Pharmaceuticals U.S.A., Inc. | ANDA 75-074 | 3/11/98 | 3/19/99 | ||
| Etodolac Tablets, 400 mg | Chelsea Laboratories | ANDA 75-069 | 4/16/98 | 5/6/98 | 3/19/99 | |
| Etodolac Tablets, 400 mg and 500 mg, Rx | Genpharm | ANDA 75-012 | 9/30/98 | 9/30/98 | ||
| Etodolac Tablets, 400 mg. | Teva Pharmaceuticals | ANDA 75-009/S2, S3, S4, S5 & S6 | 12/28/99 | 9/24/02 | ||
| Etodolac Tablets, 400 mg. | Mylan Pharmaceuticals, Inc. | ANDA 75-104 | 2/6/98 | 3/22/99 | ||
| Etodolac Tablets, 400 mg and 500 mg | Novopharm Limited | ANDA 74-847 | 4/23/99 | 4/28/99 | ||
| Etopophos (etoposide phosphate) for injection, 100 mg, 500 mg and 1gram. | Bristol-Myers Squibb Company | NDA 20-457/S-006 NDA 20-906/S-002 |
11/5/02 | 11/18/02 | ||
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