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 |
|---|---|---|---|---|---|---|
| Vagifem (17-B-Estradiol) Vaginal Tablets, 25ug, Rx | Novo Nordisk Pharmaceuticals | NDA 20-908 | 3/26/99 | 3/30/99 | 3/30/99 | |
| Valcyte (valganciclovir HCI) Tablets, 450 mg, Rx | Hoffman-La Roche Inc. | NDA 21-304/S1 | 9/12/03 | 9/25/03 | 9/25/03 | |
| Valcyte (valganciclovir HCI) Tablets, 450 mg, Rx | Roche Global Development-Palo | NDA 21-304 | 3/29/01 | 4/13/01 | 4/13/01 | 4/12/04 |
| Valcyte Indications: Treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). | ||||||
| Valium (diazepam) Tablets & Injection, | Roche Products Inc. | NDA 13-263/S72/75 & 16-087/S79/81 | 2/7/02 | 4/16/02 | ||
| Valium (diazepam) Tablets, 2 mg, 5 mg, and 10 mg | Hoffmann-La Roche Inc. | NDA 13-263/S-086 | 2/12/02 | 3/7/02 | ||
| Valium (diazepam) Tablets, 2 mg, 5 mg, and 10 mg | Hoffmann-La Roche Inc. | NDA 13-263/S-082 | 5/9/01 | 5/16/02 | ||
| Valproate Sodium Injection, 100 mg (base)/mL, Rx | American Pharmaceutical Partners | ANDA 76-539 | 6/26/03 | |||
| Valproic Acid Syrup USP, 250 mg/5 mL, Rx | UDL Laboratories, Inc. | ANDA 75-782 | 12/22/00 | 3/5/01 | ||
| Valproic Acid Syrup USP, 250 mg/5 mL, Rx | Pharmaceutical Associates, Inc. | ANDA 75-379 | 12/15/00 | 3/6/01 | ||
| Valstar (valrubicin) Sterile Solution for Intravesical Instillation, 5 mL, Single-Use Vials (40 mg/mL) | Anthra Pharmaceuticals | NDA 20-892 | 9/25/98 | 9/28/98 | 9/28/98 | 7/8/99 |
| Valstar Indication: intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. | ||||||
| Valtrex (valacyclovir hydrochloride) Capsules, Rx | GlaxoSmithKline | NDA 20-550/S21 | 8/8/03 | 8/15/03 | ||
| Valtrex (valacyclovir
hydrochloride) Caplets, 500 mg, Rx |
GlaxoSmithKline | NDA 20-550/S19 | 8/29/03 | 9/09/03 | 8/29/03 | |
| Valtrex Indication: Reduction of the risk of transmission of genital herpes during suppressive therapy of the source partner in a heterosexual couple. | ||||||
| Valtrex (valacyclovir hydrochloride), Rx | GlaxoSmithKline | NDA 20-550/S10, S13 | 6/25/01 | 4/25/03 | ||
| Valtrex (valacyclovir hydrochloride), Rx | GlaxoSmithKline | NDA 20-550/S16 | 9/9/02 | 9/11/02 | ||
| Valtrex (valacyclovir hydrochloride), Rx | GlaxoSmithKline | NDA 20-550S12 | 7/13/01 | 11/6/01 | 11/6/01 | |
| Valtrex (valacyclovir hydrochloride) 500 mg and 1 gram Caplets. | GlaxoSmithKline | NDA 20-550/S-005 | 4/1/03 | 4/18/03 | 4/18/03 | |
| Valtrex (valacyclovir hydrochloride) Caplets, 500 mg, Rx | GlaxoSmithKline | NDA 20-550 | 6/25/01 | |||
| Vanceril (Beclomethasone Dipropionate) Inhalation Aerosol | Schering Corporation | NDA 17-573/S040 | 2/8/99 | 6/22/01 | ||
| Vancocin HCl (vancomycin hydrochloride) Pulvules, | Eli Lilly and Company | NDA 50-606/S19 | 3/17/04 | 3/23/04 | ||
| Vancocin HCl (vancomycin hydrochloride capsules, USP) Pulvules, 125, 250 mg, | Eli Lilly and Company | NDA 50-606/S15 | 5/24/02 | 6/3/02 | ||
| Vancocin HCL (vancomycin) Injection, USP | Baxter Healthcare Corporation | NDA 50-671/S6 | 3/30/04 | 4/7/04 | 4/6/04 | |
| Vancocin HCL (vancomycin) Injection, USP | Baxter Healthcare Corporation | NDA 50-671/S-002 | 1/8/98 | 7/27/99 | ||
| Vaniqa (eflornithine hydrochlorine) Cream,13.9%, Rx | Bristol-Myers Squibb | NDA 21-145 | 7/27/00 | 8/3/00 | 8/3/00 | 7/8/03 |
| Vaniqa Indications: For the reduction of unwanted facial hair in women. | ||||||
| Vantin (cefpodoxime proxetil) Oral Suspension, 5 mg/kg | Pharmacia & Upjohn | NDA 50-675/S-014 | 11/20/98 | 11/20/98 | 8/1/01 | |
| Vantin (cefpodoxime proxetil) Tablets and Vantin® (cefpodoxime proxetil) Oral Suspension. | Pharmacia & Upjohn | NDA 50-674/S-012 50-675/S-015 |
11/20/98 | 11/20/98 | 7/27/99 | |
| Vaseretic (Enalapril Maleate/Hydrochlorothiazide) Tablets & Vasotec (Enalaprilat) IV, 10/25 mg & 1.25 mg/mL, respectively, Rx | Merck | NDA 19-221/S-027 & 19-309/S-025 | 10/30/02 | 11/19/02 | ||
| Vaseretic (Enalapril Maleate/Hydrochlorothiazide) Tablets, 5/12.5 & 10/25 mg | Merck | NDA 19-221/S-024 | 10/13/98 | 6/25/99 | ||
| Vasotec I.V. (Enalapril), (Enalapril Maleate) Tablets, & (Enalapril Maleate/Hydrochlorothiazide) Tablets, | Merck and Company, Inc. | NDA 19-309/S23 18-998/S058 & 19-221/S26 | 11/27/01 | 7/5/02 | ||
| Vasotec (Enalapril Maleate) Tablets, 2.5, 5 10 and 20 mg | Biovail Technologies Ltd. | NDA 18-998/S063 | 8/30/02 | 9/11/02 | ||
| Vasotec (Enalapril Maleate) Tablets, 2.5, 5 10 and 20 mg | Merck and Company, Inc. | NDA 18-998/S059 | 2/13/01 | 7/18/01 | ||
| Vecuronium Bromide for Injection, 4 mg/ampul, Rx | Abbott Laboratories | ANDA 75-558 | 9/11/01 | 4/14/03 | ||
| Vecuronium Bromide for Injection, 10 mg/vial and 20 mg/vial, Rx | Bedford Laboratories | ANDA 75-549 | 6/13/00 | 6/16/00 | ||
| Vecuronium Bromide for Injection, 10 mg/vial and 20 mg/vial. | Abbott Laboratories | ANDA 75-164 | 10/21/99 | 12/30/99 | 7/11/01 | |
| Vecuronium Bromide for Injection, 10 mg/10 mL vial & 20 mg/20 mL vial. (Tentatively Approved 7/30/99) | ESI Lederle | NDA 75-218 | 7/30/99 | 8/4/99 | ||
| Vecuronium Bromide Injection, 10 mg/10 mL vial & 20 mg/20 mL vial | ESI Lederle | ANDA 75-218 | 8/23/99 | 8/26/99 | ||
| Vecuronium Bromide Injection, 10 mg vial & 20 mg vial | Gensia Sicor Pharmaceuticals, Inc. | ANDA 74-688 | 8/25/99 | 8/26/99 | ||
| Velcade (bortezomib) for Injection, 3.5 mg, Rx | Millennium Pharmaceuticals | NDA 21-602 | 5/13/03 | 6/9/03 | 5/14/03 | 9/25/03 |
| Velosulin BR (rDNA) Injection, OTC | Novo Nordisk | NDA 21-028 | 7/19/99 | 7/28/99 | 7/28/99 | 6/30/00 |
| Venofer (iron sucrose) injection, Rx | Luitpold Pharmaceuticals | NDA 21-135/S6 | 6/2/03 | 7/24/03 | ||
| Venofer (iron sucrose injection), Rx | Luitpold Pharmaceuticals, Inc. | NDA 21-135 | 11/7/00 | 11/13/00 | 11/13/00 | 6/7/01 |
| Ventolin (albuterol) inhalation aerosol, Rx | GlaxoSmithKline | NDA 18-473 | 6/20/03 | 7/6/03 | ||
| Ventolin HFA (albuterol sulfate inhalation aerosol), Rx | GlaxoSmithKline | NDA 20-983 | 4/19/01 | 5/1/01 | 4/30/01 | 3/28/02 |
| Ventolin Indications: treatment or prevention of bronchospasm in adults and children 4 years of age and older with reversible obstructive disease and for the prevention of exercise-induced bronchospasm in patients 4 years of age and older. | ||||||
| VePesid (etoposide) Capsules | Bristol-Myers Squibb Company | NDA 19-557/S23 | 4/2/99 | 7/6/00 | ||
| VePesid (etoposide) Capsules | Bristol-Myers Squibb Company | NDA 18-768/S41 | 4/2/99 | 7/5/00 | ||
| VePesid (etoposide) Injection, 100 mg, 500 mg and 1gram, Rx | Bristol-Myers Squibb Company | NDA 18-768/S45 & 19-557/S28 | 11/5/02 | 11/19/02 | ||
| Verapamil Hydrochloride Injection USP, 2.5 mg/mL, (4 mL fil in a 5 mL plastic syringe), Rx | Abbott Laboratories | ANDA 75-136 | 10/20/98 | 10/26/98 | 9/25/02 | |
| Verapamil Hydrochloride Extended-release Capsules, 120 mg, 180 mg, 240 mg, Rx | Mylan Pharmaceuticals | ANDA 75-138 | 4/20/99 | 4/28/99 | 1/3/02 | |
| Verapamil Hydrochloride Extended-release Tablets USP, 120 mg & 240 mg, Rx | Duramed Pharmaceuticals, Inc. | ANDA 75-072 | 5/25/99 | 6/1/99 | 8/23/01 | |
| Verelan PM (verapamil hydrochloride) Capsules, | Elan Pharmaceutical Research Corp. | NDA 20-943 | 11/25/98 | 11/25/98 | 12/1/98 | 8/14/02 |
| Verelan PM Indication: Hypertension | ||||||
| Versed Oral Syrup, | Hoffmann - La Roche | NDA 020942 | 10/15/98 | 8/13/03 | ||
| Vesanoid (Tretinoin) Capsules, 10 mg, Rx | Roche, Inc. | NDA 20-438/S1 | 2/14/00 | 11/19/02 | 11/19/02 | 4/14/04 |
| Vexol (rimexolone ophthalmic suspension), 0.1%, Rx | Alcon Laboratories, Inc. | NDA 20-474/S-016 | 4/17/03 | |||
| VFEND (voriconazole) Tablets, Injection & Oral Suspension, Rx | Pfizer Inc. | NDA 21-266/S5/S6, 21-267/S5/S6 & 21-630/S1 | 4/21/04 | |||
| VFEND (voriconazole) Oral Suspension, Rx | Pfizer, Inc. | NDA 21-630 | 12/19/03 | 12/24/03 | 12/29/03 | |
| VFEND (voriconazole) Tablets & Injection, Rx | Pfizer, Inc. | NDA 21-464 & 21-466 | 11/14/03 | 11/25/03 | 12/8/03 | |
| VFEND (voriconazole) Tablets & Powder for Injection, 50& 200 mg and 200 mg, respectively, Rx | Pfizer, Inc. | NDA 21-266/S-002 & 21-267/S-003 | 3/28/03 | 4/14/03 | 4/1/03 | |
| VFEND (voriconazole) Tablets & VFEND (voriconazole for infusion), Rx | Pfizer Inc. | NDA 21-266/S7 & 21-267/S7 | 2/4/04 | 3/3/04 | 4/5/04 | |
| VFEND (voriconazole) Tablets & VFEND (voriconazole for infusion), Rx | Pfizer Inc. | NDA 21-266 & 21-267 | 5/24/02 | 6/3/02 | 5/28/02 | 9/25/03 |
| Viadur (leuprolide acetate implant), Rx | ALZA Corporation | NDA 21-088/S15 | 8/1/03 | 8/15/03 | ||
| Viadur (leuprolide acetate implant), Rx | ALZA Corporation | NDA 21-088 | 3/3/00 | 3/7/00 | 3/7/00 | 2/28/02 |
| Viadur Indication: palliative treatment of advanced prostate cancer. | ||||||
|
Viagra (Sildenafil Citrate) Tablets,
Rx Viagra Information Page |
Pfizer, Inc. | NDA 20-895/S11, S15 & S18 | 9/19/02 | 10/2/02 | 9/20/02 | |
|
Viagra (Sildenafil Citrate) Tablets,
Rx Viagra Information Page |
Pfizer | NDA 20-895 | 3/27/98 | 3/27/98 | 11/24/98 | 3/27/98 |
| Vibramycin Monohydrate Oral Suspension, Capsules, Vibramycin Calcium Syrup, & Vibra-Tabs (doxycycline hyclate) Film Coated Tablets, | Pfizer, Inc. | NDA 50-006/S76, 50-007/S16, 50-480/S37, 50-533/S32 | 3/12/04 | 3/16/04 | ||
| Vibramycin Monohydrate (doxycycline monohydrate) Oral Suspension, Vibramycin Capsules, Intravenous, Vibramycin Calcium (doxycycline calcium oral suspension) Syrup, Vibra-Tabs (doxycycline hyclate) Film Coated Tablets, | Pfizer, Inc. | NDA 50-006/S-074, 50-007/S-014, 50-442/S-015, 50-480/S-035, 50-533/S-030 | 6/18/02 | 6/24/02 | ||
| Videx EC (didanosine) Chewable dispersible buffered tablets, Rx | Bristol-Myers Squibb | NDA 20-154/S35, S36 | 9/10/01 | 4/21/03 | ||
| Videx EC (didanosine) Chewable dispersible buffered tablets, Rx | Bristol-Myers Squibb | NDA 20-155/S26 | 9/10/01 | 4/21/03 | ||
| Videx EC (didanosine) Chewable dispersible buffered tablets, Rx | Bristol-Myers Squibb | NDA 20-155/S27 | 9/10/01 | 4/21/03 | ||
| Videx EC (didanosine) Chewable dispersible buffered tablets, Rx | Bristol-Myers Squibb | NDA 20-156/S28 | 9/10/01 | 4/21/03 | ||
| Videx EC (didanosine) Chewable dispersible buffered tablets, Rx | Bristol-Myers Squibb | NDA 20-156/S28 | 9/10/01 | 4/21/03 | ||
| Videx EC (didanosine) Delayed Release Capsules, Rx | Bristol-Myers Squibb | NDA 21-183/S5/S6 | 9/26/02 | 10/2/02 | 9/27/02 | |
| Videx EC (didanosine) Delayed Release Capsules, Rx | Bristol-Myers Squibb | NDA 21-183/S4 | 8/5/02 | 8/12/02 | 8/5/02 | |
| Videx EC (didanosine) Delayed Release Capsules, Rx | Bristol-Myers Squibb | NDA 21-183/S2 | 1/29/02 | 3/6/02 | ||
| Videx EC (didanosine) Delayed Release Capsules, Rx | Bristol-Myers Squibb | NDA 21-183/S1 | 1/28/02 | 3/6/02 | ||
| Videx EC, Rx | Bristol-Myers Squibb | NDA 21-183 | 10/31/00 | 1/5/01 | 3/11/04 | |
| Videx EC Indications: in combination with other antiretroviral agents, as indicated for the treatment of HIV-1 infection in adults whose management requires once-daily administration of didanosine or an alternative didanosine formulation. | ||||||
| VIDEX (didanosine) Chewable Tablets, Buffered/Pediatric Powder for Oral Solution, & Delayed-Release Capsules, | Bristol-Myers Squibb | NDA 20-154/S-044, 20-155/S34, 20-156/S35 & 21-183/S10 | 1/21/04 | 1/22/04 | 1/22/04 | |
| VIDEX (didanosine) Buffered Tablets, Buffered Powder for Oral Solution, & Pediatric Powder, | Bristol-Myers Squibb Company | NDA 20-154/S-040 & s-041, 20-155/S-030 & S-031, 20-156/S-031 & S-032 | 9/25/02 | 10/2/02 | 9/25/02 | |
| VIDEX (didanosine) Buffered Tablets, Buffered Powder for Oral Solution, & Pediatric Powder, & VIDEX® EC (didanosine) Delayed Release Capsules, | Bristol-Myers Squibb Company | NDA 20-154/S-42, 20-155/S-32, 20-156/S-33 & 21-183/S-7 | 3/4/03 | 3/10/03 | 3/6/03 | |
| VIDEX (didanosine) Buffered Tablets, Buffered Powder for Oral Solution, & Pediatric Powder, & VIDEX® EC (didanosine) Delayed Release Capsules, | Bristol-Myers Squibb Company | NDA 20-154/S-037, 20-155/S-028, 20-156/S-029 & 21-183/S-003 | 4/1/02 | 4/8/02 | 4/2/02 | |
| VIDEX (didanosine) chewable/dispersible tablets, Buffered Powder for Oral Solution, and Pediatric Powder for Oral Solution, Rx | Bristol-Myers Squibb | NDA 20-154/S29, S30 20-155/S21 20-156/S22 |
10/29/99 | 12/30/99 | 12/30/99 | |
| Vigamox (moxifloxacin hydrochloride) Ophthalmic Solution, 0.5%, Rx | Alcon, Inc. | NDA 21-598/S2 | 4/12/04 | |||
| Vigamox (moxifloxacin hydrochloride) Ophthalmic Solution, 0.5%, Rx | Alcon, Inc. | NDA 21-598/S1 & S5 | 10/3/03 | 10/10/03 | 10/10/03 | |
| Vigamox (moxifloxacin hydrochloride ophthalmic solution), 0.5%, Rx | Alcon, Inc. | NDA 21-598 | 4/15/03 | 4/17/03 | ||
| Vincristine Sulfate Injection, 1 mg/mL, Rx | American Pharmaceutical Partners, Inc. | ANDA 76-401 | 10/28/03 | |||
| Vincristine Sulfate Injection, 1 mg/1 mL, Rx | American Pharmaceutical Partners, Inc. | ANDA 76-296 | 12/20/02 | |||
| Vincristine Sulfate Injection, 1 mg/1 mL & 2 mg/2 mL | Gensia Sicor | ANDA 75-493 | 9/1/99 | 9/14/99 | 12/6/01 | |
| Vinorelbine Tartrate Injection, 10 mg, Rx | Bedford Laboratories | ANDA 76-461 | 12/11/03 | |||
| Vinorelbine Tartrate Injection, 10 mg, Rx | Gensia Sicor Pharmaceuticals, Inc. | ANDA 76-028 | 2/3/03 | |||
| Vinorelbine
Tartrate Injection, 10 mg, Rx Tentative Approval - September 17, 2002 |
Gensia Sicor Pharmaceuticals, Inc. | ANDA 76-028 | 9/17/02 | |||
| Vinorelbine Tartrate Injection, Rx | ESI Lederle | ANDA 75-992 | 6/10/03 | |||
| Vioxx (rofecoxib) Tablets, Rx | Merck & Co. Inc. | NDA 21-647 | 3/26/04 | 3/28/04 | 4/6/04 | |
| Vioxx (rofecoxib) Tablets, 50 mg, Rx | Merck & Co. Inc. | NDA 21-042/S23 | 12/16/03 | 12/19/03 | ||
| Vioxx (rofecoxib tablets) Tablets, 12.5 mg and 25 mg., Rx | Merck Research Laboratories | NDA 21-042 | 5/20/99 | 5/21/99 | 5/21/99 | 4/17/00 |
| Vioxx Indication: For relief of the signs and symptoms of osteoarthritis. For the management of acute pain. For the treatment of primary dysmenorrhea. | ||||||
| Vioxx (rofecoxib) Tablets & Suspension, Rx | Merck & Co. Inc. | NDA 21-042/S24 & 21-052/S17 | 12/16/03 | 12/19/03 | ||
| Vioxx (rofecoxib) Tablets & Suspension, Rx | Merck & Co. Inc. | NDA 21-042/S18 & 21-052/S12 | 8/6/03 | 8/15/03 | 8/15/03 | |
| Vioxx (rofecoxib) Tablets & Suspension, Rx | Merck & Co. Inc. | NDA 21-042/S-017 &21-052/S-011 | 5/19/03 | |||
| Vioxx (rofecoxib) Tablets & Suspension, 12.5, 25, 50 mg & 12.5 mg/mL and 25 mg/mL respectively, Rx | Merck & Co. Inc. | NDA 21-042/S-020, S-021, S-022 & 21-052/S-014, S-015, S-016 | 6/27/03 | 7/6/03 | ||
| Vioxx (rofecoxib) Tablets & Suspension, 12.5, 25, 50 mg & 12.5 mg/mL and 25 mg/mL respectively, Rx | Merck & Co. Inc. | NDA 21-042/S-007, S-008, S-010, S-012, S-013, S-014 & NDA 21-052/S-004, S-005, S-006, S-007, S-008, S-009 | 4/11/02 | 4/16/02 | 4/16/02 | 7/25/02 |
| Vioxx (rofecoxib oral suspension) Oral Suspension, 12.5 mg/mL and 25 mg/mL, Rx | Merck Research Laboratories | NDA 21-052 | 5/20/99 | 6/30/00 | ||
| Vioxx Indication: For relief of the signs and symptoms of osteoarthritis. For the management of acute pain. For the treatment of primary dysmenorrhea. | ||||||
| VIRACEPT (nelfinavir mesylate) Tablets, 625 mg, Rx | Agouron Pharmaceuticals | NDA 21-503 | 4/30/03 | |||
| VIRACEPT (nelfinavir mesylate) Tablets and Oral Powder, | Pfizer Inc. | NDA 20-779/S42 20-778/S22 & 21-503/S1 | 3/19/04 | 3/23/04 | 4/7/04 | |
| VIRACEPT (nelfinavir mesylate) Tablets and Oral Powder, 250mg & 50mg/g | Agouron Pharmaceuticals, Inc. | NDA 20-779/S41 20-778/S20 & 21-503/S2 | 8/22/03 | 8/28/03 | 8/28/03 | |
| VIRACEPT (nelfinavir mesylate) Tablets and Oral Powder, 250mg & 50mg/g | Agouron Pharmaceuticals, Inc. | NDA 20-779/S22 | 4/23/03 | |||
| VIRACEPT (nelfinavir mesylate) Tablets and Oral Powder, 250mg & 50mg/g | Agouron Pharmaceuticals, Inc. | NDA 20-778/S18 & 20-779/S39 | 12/20/02 | 7/30/03 | 4/4/03 | |
| VIRACEPT (nelfinavir mesylate) Tablets and Oral Powder, 250mg & 50mg/g | Agouron Pharmaceuticals, Inc. | NDA 20-778/S16, 20-778/S17, 20-779/S37 & 20-779/S38 | 2/5/02 | 4/17/02 | ||
| VIRACEPT (nelfinavir mesylate) Tablets and Oral Powder, 250mg & 50mg/g | Agouron Pharmaceuticals, Inc. | NDA 20-778/S14, 20-779/S32 | 4/11/01 | 4/9/03 | ||
| VIRAMUNE (nevirapine) Tablets and Suspension, | Boehringer Ingleheim Pharmaceuticals, Inc. | NDA 20-636/S21 & 20-933/S11 | 12/22/03 | 12/23/03 | 12/29/03 | |
| VIRAMUNE (nevirapine) Tablets and Suspension, | Boehringer Ingleheim Pharmaceuticals, Inc. | NDA 20-636/S20 & 20-933/S10 | 7/29/03 | 8/6/03 | 8/6/03 | |
| VIRAMUNE (nevirapine) Tablets and Suspension, | Boehringer Ingleheim Pharmaceuticals, Inc. | NDA 20-636/S-016 & 20-933/S-006 | 12/31/02 | 1/29/03 | 4/3/03 | |
| Viramune (Nevirapine) Tablets & Oral Solution, | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA 20-636/S9 & 20-933 | 9/11/98 | 2/4/04 | ||
| Viramune (Nevirapine) Tablets & Oral Solution, | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA 20-636/S17 & 20-933/S7 | 3/27/02 | 4/8/02 | ||
| VIREAD (tenofovir disoproxil fumarate) Tablets, 300 mg, Rx | Gilead Sciences | NDA 21-356/S6 | 10/31/03 | 11/25/03 | 12/1/03 | |
| VIREAD (tenofovir disoproxil fumarate) Tablets, 300 mg, Rx | Gilead Sciences, Inc | NDA 21-356/S5 | 10/14/03 | 10/16/03 | 10/16/03 | |
| VIREAD (tenofovir disoproxil fumarate) Tablets, 300 mg, Rx | Gilead Sciences, Inc | NDA 21-356/S3 | 8/15/03 | 8/28/03 | 8/28/03 | |
| VIREAD (tenofovir disoproxil fumarate) Tablets, 300 mg, Rx | Gilead Sciences, Inc | NDA 21-356/S1 | 12/2/02 | 12/9/02 | 12/2/02 | |
| VIREAD (tenofovir disoproxil fumarate) Tablets, 300 mg | Gilead Sciences, Inc | NDA 21-356 | 10/26/01 | 11/2/01 | 11/2/01 | 1/14/02 |
| VIREAD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. | ||||||
| Viroptic (trifluridine ophthalmic solution) 1% Sterile | Monarch Pharmaceuticals, Inc. | NDA 18-299S-014 | 2/20/02 | 2/21/02 | ||
| Visicol (sodium phosphate monobasic monohydratde, USP and sodium phosphate dibasic anhydrous, USP) Tablets, Rx | InKine Pharmaceutical Company, Inc. | NDA 21-097/S5 | 3/12/02 | 4/8/02 | ||
| Visicol (sodium phosphate monobasic monohydratde, USP and sodium phosphate dibasic anhydrous, USP) Tablets, Rx | InKine Pharmaceutical Company, Inc. | NDA 21-097 | 9/21/00 | 9/29/00 | 9/29/00 | 12/11/01 |
| Visicol Indication: cleansing of the bowel as a preparation for colonscopy in adults 18 years of age or older. | ||||||
| Visine-A (0.025% naphazoline hydrochloride and 0.3% pheniramine maleate) ophthalmic solution, | Pfizer | NDA 20-485/S-006 | 9/15/03 | 9/25/03 | 9/25/03 | |
| Visine-A (0.025% naphazoline hydrochloride and 0.3% pheniramine maleate ophthalmic solution), | Pfizer, Inc. | NDA 20-485/S-005 | 6/14/02 | 6/17/02 | 6/14/02 | |
| Visine L.R. (oxymetazoline HCl 0.05%) Eye Drops, | Pfizer Inc. | NDA 19-407/S-010 | 8/23/02 | 8/30/02 | ||
| Visipaque (iodixanol) Injection, Rx | Amersham Health | NDA 20-351/S16 | 3/24/04 | 3/28/04 | ||
| Visipaque (iodixanol) Injection, Rx | Amersham Health | NDA 20-351/S13 | 12/18/03 | 12/23/03 | 12/29/03 | |
| Visipaque (iodixanol) Injection, Rx | Amersham Health | NDA 20-351/S-011 | 9/4/03 | 9/25/03 | ||
| Visipaque (iodixanol) Injection, Rx | Amersham Health | NDA 20-351/S-010 | 12/3/02 | 12/9/02 | ||
| Visipaque (iodixanol) Injection, Rx | Amersham Health | NDA 20-808/S4 | 12/18/03 | 12/23/03 | 12/29/03 | |
| Visipaque (iodixanol) Injection, Rx | Amersham Health | NDA 20-808/S002 | 9/4/03 | 9/25/03 | ||
| Visipaque (iodixanol) Injection, Rx | Nycomed Inc. | NDA 20-808/S001 | 1/28/99 | 6/15/01 | ||
| Vistide (cidofovir injection) 75 mg/mL | NDA 20-638 | 3/9/99 | ||||
| Vistide Indications: For the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS. | ||||||
| Visudyne (verteporfin) Injection, 15 mg, Rx | QLT, Inc. | NDA 21-119/S6 & S10 | 2/12/04 | 3/3/04 | ||
| Visudyne (verteporfin) Injection, 15 mg, Rx | QLT, Inc. | NDA 21-119/S005 | 11/25/02 | 12/9/02 | 11/26/02 | |
| Visudyne (verteporfin) Injection, 15 mg, Rx | QLT, Inc. | NDA 21-119/S004 | 5/29/02 | 6/3/02 | 5/31/02 | |
| Visudyne (verteporfin) Injection, 15 mg, Rx | QLT, Inc. | NDA 21-119/S003 | 4/30/02 | 5/2/02 | 5/1/02 | |
| Visudyne (verteporfin) Injection, 15 mg, Rx | QLT, Inc. | NDA 21-119/S001 | 8/22/01 | 11/6/01 | 11/6/01 | 12/12/01 |
| Visudyne (verteporfin) Injection, 15 mg, Rx | QLT Photo Therapeutics | NDA 21-119 | 4/12/00 | 4/17/00 | 4/17/00 | 12/11/01 |
| Visudyne Indications: for the treatment of age-related macular degeneration in patients with predominantly classic subfoveal choroidal neovascularization. | ||||||
| Vitravene Injection (fomivirsen sodium intravitreal injectable), 6.6mg, Rx | Isis Pharmaceuticals | NDA 20-961 | 8/26/98 | 8/28/98 | 8/28/98 | 4/10/02 |
| Vitravene Indications: Vitravene Injection for the local treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS) who are intolerant of or have a contraindication to other treatment(s) for CMV retinitis or who were insufficiently responsive to previous treatment(s) for CMV retinitis. | ||||||
| Vivelle, Rx | Novartis | NDA 21-167 & 20-323/S-023 | 8/16/00 | 8/23/00 | 8/23/00 | 3/11/04 |
| Vivelle Indications: Prevention of postmenopausal osteoporosis. | ||||||
| Vivelle (estradiol) transdermal system, Rx | Novartis | NDA 20-323/S17, S25 & S30 | 1/22/04 | 2/2/04 | 2/2/04 | |
| Vivelle, 0.0375 mg, Rx | Novartis | NDA 20-323S21 | 2/28/00 | 2/29/00 | 2/29/00 | 3/26/04 |
| Vivelle Indications: Treatment of moderate-to-severe vasomotor symptoms associated with the menopause treatment of vulvar and vaginal atrophy treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure. | ||||||
| Vivelle-Dot (estradiol transdermal system), | Novartis Pharmaceuticals | NDA 20-538/S19 | 1/28/04 | 2/2/04 | 2/2/04 | |
| Vivelle-Dot (estradiol transdermal system), | Novartis Pharmaceuticals Corporation | NDA 20-538/S-012, S-014 & S-015 | 5/3/02 | 5/21/02 | 5/6/02 | |
| Voltaren (diclofenac sodium) Tablets, 25, 50, and 75 mg., Rx | Ciba Pharmaceuticals | NDA 19-201/S-018 | 11/26/02 | 12/6/02 | ||
| Vontrol Tablets | GlaxoSmithKline | NDA 16-033/S-011 | 8/6/01 | 11/21/02 | 5/14/03 | |
| Vumon (teniposide) for Injection Concentrate, | Bristol-Myers Squibb Company | NDA 20-119/S4 | 10/1/02 | 10/2/02 | ||
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.
