|
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 |
|---|---|---|---|---|---|---|
| Tabloid (thioguanine) Tablets, 40 mg | GlaxoSmithKline | NDA 12-429/S21 | 12/19/03 | 12/24/03 | 12/29/03 | |
| Tabloid (thioguanine) Tablets, 40 mg | SmithKline | NDA 12-429/S-019 | 6/30/03 | 7/6/03 | 7/8/03 | |
|
Tagamet HB 200
(cimetidine) Suspension, oral suspension, OTC. |
SmithKline Beecham Consumer Healthcare. | NDA 20-951 | 7/9/99 | 9/24/99 | 9/24/99 | 5/18/00 |
| Talacen (pentazocine HCl and acetaminophen) Caplets, | Sanofi-Synthelabo | NDA 18-458/S-012 | 7/10/03 | 7/28/03 | ||
| Talwin NX (pentazocine HCl and naloxone HCl) Tablets, Rx | Sanofi-Synthelabo | NDA 18-733/S-012 | 2/26/03 | 3/10/03 | ||
| Tamiflu (oseltamivir phosphate) capsules and oral suspension, | Hoffman-La Roche Inc. | NDA 21-087/S-010 & 21-246/S-007 | 4/26/02 | 5/2/02 | 4/26/02 | |
| Tamiflu (oseltamivir phosphate) capsules and oral suspension, | Hoffman-La Roche Inc. | NDA 21-087/S-010 & 21-246/S-007 | 4/9/02 | 4/16/02 | 4/9/02 | |
| Tamiflu (oseltamivir phosphate) capsules and oral suspension, | Hoffman-La Roche Inc. | NDA 21-087/S-009 & 21-246/S-004 | 11/5/01 | 4/22/03 | ||
| Tamiflu (oseltamivir phosphate) capsules and oral suspension, | Hoffman-La Roche Inc. | NDA 21-087/S-008 & 21-246/S-003 | 07/24/01 | 05/08/03 | ||
| Tamiflu (oseltamivir phosphate) capsules and oral suspension, | Hoffman-La Roche Inc. | NDA 21-087/S5/S6 | 07/24/01 | 05/08/03 | ||
|
Tamiflu (oseltamivir phospate)
Oral Suspension,12mg/mL [Patient Labeling] |
Hoffman-La Roche | NDA 21-246 | 12/14/00 | 12/15/00 | 12/14/00 | |
| Tamiflu indication: Tamiflu is now available for oral use for the treatment of uncomplicated acute illness due to influenza in patients older than one year of age who have been symptomatic for no longer than 2 days. Tamiflu treatment significantly reduced the total composite time to freedom from illness (resolution of fever, alleviation of coryza and cough, and parental opinion of return to normal health and activity) by 1.5 days compared to placebo. | ||||||
|
Tamiflu (oseltamivir phospate)
Oral Suspension,12mg/mL |
Hoffman-La Roche | NDA 21-246/S1 | 7/24/01 | 5/1/03 | ||
| Tamiflu (oseltamivir phospate) Oral Suspension,12mg/mL | Hoffman-La Roche | NDA 21-246/S3 | 7/24/01 | 5/1/03 | ||
| Tamiflu (oseltamivir phospate), 75 mg capsule [Patient Labeling] | Hoffman-La Roche | NDA 21-087/SE1-002 | 11/17/00 | 12/15/00 | 12/14/00 | 4/14/04 |
| Tamiflu (oseltamivir phospate)75 mg capsule | Hoffman-La Roche | NDA 21-087 | 10/27/99 | 12/30/99 | 12/30/99 | 5/29/01 |
| Tamoxifen Citrate Tablets USP, 10 & 20 mg (base), Rx | Andrx Pharmaceuticals | ANDA 76-179 | 2/20/03 | |||
| Tamoxifen Citrate Tablets USP, 10 & 20 mg (base), Rx Tentatively Approved | Andrx Pharmaceuticals, Inc. | ANDA 76-179 | 7/10/02 | |||
| Tamoxifen Citrate Tablets USP, 10 & 20 mg (base), Rx | Roxane Laboratories | ANDA 76-027 | 2/20/03 | |||
| Tamoxifen Citrate Tablets USP, 10 mg (base), Rx | Teva Pharmaceuticals | ANDA 75-797 | 2/20/03 | |||
| Tamoxifen Citrate Tablets USP, 10 mg (base), Rx Tentatively Approved | Teva Pharmaceuticals USA | ANDA 75-797 | 2/14/01 | 3/6/01 | ||
| Tamoxifen Citrate Tablets USP, 10 & 20 mg (base), Rx | IVAX Pharmaceuticals | ANDA 75-740 | 2/20/03 | |||
| Tamoxifen Citrate Tablets USP, 20 mg (base), Rx | Pharmachemie B.V. | ANDA 74-858 | 2/20/03 | |||
| Tamoxifen Citrate Tablets USP, 10 & 20 mg (base), Rx | Mylan Phrmaceuticals | ANDA 74-732 | 2/20/03 | |||
| Tamoxifen Citrate Tablets USP, 10 & 20 mg (base), Rx Tentatively Approved | Mylan Phrmaceuticals Inc. | ANDA 74-732 | 3/21/02 | 10/29/02 | ||
| Tamoxifen Citrate Tablets USP, 10 mg (base), Rx Tentatively Approved | Mylan Phrmaceuticals Inc. | ANDA 74-732 | 6/26/00 | 10/30/00 | ||
| Tamoxifen Citrate Tablets USP, 10 mg (base), Rx Tentatively Approved | Pharmachemie B.V. | ANDA 74-539 | 3/21/02 | 10/29/02 | ||
| Tamoxifen Citrate Tablets USP, 10 mg (base), Rx | Pharmachemie B.V. | ANDA 74-539 | 5/31/00 | 6/6/00 | ||
| Tamoxifen Citrate Tablets USP, 10 mg (base) and 20 mg (base), Rx | Teva Pharmaceuticals | ANDA 74-504 | 4/28/03 | |||
| Tamoxifen Citrate Tablets USP, 10 mg (base) and 20 mg (base), Rx Tentatively Approved | Novopharm Limited | ANDA 74-504 | 6/28/00 | 10/30/00 | ||
| Tamoxifen Citrate Tablets USP, 10 mg (base) and 20 mg (base), Rx | Barr Laboratories | ANDA 70-929 | 2/20/03 | |||
| Targretin (bexarotene) Gel, 1%, Rx | Ligand Pharmaceuticals | NDA 21-056 | 6/28/00 | 7/24/00 | 7/24/00 | 7/12/01 |
| Targretin Indications: for the topical treatment of cutaneous lesions in patients with CTCL (Stage IA and IB) who have refractory or persistent disease after other therapies or who have not tolerated other therapies. | ||||||
| Targretin (bexarotene) capsules, 75 mg, Rx | Ligand Pharmaceuticals | NDA 21-055/S2 & S3 | 4/21/03 | 4/28/03 | ||
| Targretin (bexarotene) capsules, 75 mg [Patient Labeling] | Ligand Pharmaceuticals | NDA 21-055 | 12/29/99 | 1/3/00 | 1/3/00 | 4/11/02 |
| Targretin Indication: Targretin (bexarotene) capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. | ||||||
| Tasmar (tolcapone) Tablets, 100 and 200 mg | Roche | NDA 20-697 | 1/29/98 | 1/29/98 | 6/25/98 | 4/9/02 |
| Tavist Allergy/Sinus/Headache (0.335mg clemastine fumarate, 30mg pseudoephedrine hydrochloride, 500mg acetaminophen), OTC | Novartis Consumer Health | NDA 20-640/S2 | 10/17/97 | 4/14/04 | ||
| Tavist Allergy/Sinus/Headache (0.335mg clemastine fumarate, 30mg pseudoephedrine hydrochloride, 500mg acetaminophen), OTC | Novartis Consumer Health | NDA 21-082 | 3/1/01 | 3/14/01 | 3/14/01 | 8/8/02 |
| Tavist Indications: temporary relief of symptoms associated with hay fever allergic rhinitis, and the common cold. | ||||||
| Taxol (paclitaxel) Injection, Rx | Bristol-Myers Squibb | NDA 20262/S041 | 3/5/03 | 3/26/03 | ||
| Taxol (paclitaxel) Injection, Rx | Bristol-Myers Squibb | NDA 20262/S036, S037, S038 | 3/4/02 | 3/12/02 | ||
| Taxol (paclitaxel) Injection, | Bristol-Myers Squibb | NDA 20-262/S035 | 8/29/02 | 8/30/02 | ||
| Taxol (paclitaxel) Injection, 30mg/5 ml, 100 mg/16.7 ml | Bristol-Myers Squibb | NDA 20262/S026, S027, S028 | 4/9/98 | 5/6/98 | 5/8/98 | 6/15/00 |
| Taxol (paclitaxel) Injection, Rx | Bristol-Myers Squibb | NDA 20-262 / S-024 | 6/30/98 | 7/1/98 | 7/1/98 | 9/9/99 |
| Taxol indication: in combination with cisplatin, for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy | ||||||
| Taxol (paclitaxel) Injection, Rx | Bristol-Myers Squibb | NDA 20-262 / S-031 | 1/8/99 | 7/6/00 | ||
| Taxol (paclitaxel) Injection, Rx | Bristol-Myers Squibb | NDA 20-262 / S-033 | 10/25/99 | 12/30/99 | 12/30/99 | |
| Taxol (paclitaxel) Injection, Rx | Bristol-Myers Squibb | NDA 20-262 / S-036 | 6/20/00 | 6/21/00 | 6/21/00 | |
| Taxol Indications: For the first-line and subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Taxol is indicated in combination with cisplatin. | ||||||
| Taxotere (docetaxel) Injection Concentrate, 20 mg and 80 mg, Rx | Aventis Pharmaceutical Inc. | NDA 20-449/S17, S19 & S22 | 1/30/03 | 2/12/03 | 2/13/03 | |
| Taxotere (docetaxel) Injection Concentrate, 20 mg and 80 mg, Rx | Aventis Pharmaceutical Products Inc. | NDA 20-449/S19 | 7/30/02 | 8/6/02 | 7/30/02 | |
| Taxotere (docetaxel) Injection Concentrate, 20 mg and 80 mg, Rx | Aventis Pharmaceutical Products Inc. | NDA 20-449/S18 | 11/27/02 | 1/29/03 | 12/2/02 | 7/8/03 |
| Taxotere (docetaxel) Injection Concentrate, 20 mg and 80 mg, Rx | Aventis Pharmaceutical Products Inc. | NDA 20-449/S17 | 7/9/02 | 7/12/02 | ||
| Taxotere (docetaxel) Injection Concentrate, 20 mg and 80 mg, Rx | Aventis Pharmaceutical Products Inc. | NDA 20-449/S16 | 4/24/03 | |||
| Taxotere (docetaxel) Injection Concentrate, Rx | Rhone-Poulenc Rorer | NDA 20-449/ S-004 | 1/6/98 | 7/11/00 | ||
| Taxotere (docetaxel) Injection Concentrate, 20 mg and 80 mg, Rx | Rhone-Poulenc Rorer | NDA 20-449/ S-005, S-006 | 6/22/98 | 6/24/98 | ||
| Taxotere indication:For the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. | ||||||
| Taxotere (docetaxel), injectable, Rx | Rhone-Poulenc Rorer | NDA 20-449/S011 | 12/23/99 | 1/3/00 | 1/3/00 | 7/5/01 |
| Taxotere Indication:The treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy. | ||||||
| Tazorac (tazarotene) Gel, 0.05% & 0.1%, Rx | Allergan | NDA 20-600/S3 & S5 | 12/2/03 | 12/8/03 | ||
| Tazorac (tazarotene) Cream, 0.05% & 0.1%, Rx | Allergan | NDA 21-184 | 9/29/00 | 10/10/00 | 10/16/00 | 3/28/04 |
| Tazorac (tazarotene) Cream, 0.1%, Rx | Allergan Inc. | NDA 21-184/S1 | 10/24/01 | 11/6/01 | 11/6/01 | 12/12/01 |
| Indication: Treatment for Plaque Psoriasis. | ||||||
| Taztia XT (Diltiazem Hydrochloride Extended-release Capsules USP, 120, 180, 240, 300, and 360 mg, Rx | Andrx Pharmaceuticals | ANDA 75-401 | 4/10/03 | |||
| Taztia XT (Diltiazem Hydrochloride Extended-release Capsules USP,120, 180, 240, 300, and 360 mg, Rx Tentatively Approved | Andrx Pharmaceuticals, Inc. | ANDA 75-401 | 9/29/00 | 10/30/00 | ||
| Teczem (Enalapril Maleate/Diltiazem Maleate) Tablets, Prinzide (lisinopril/HCTZ) Tablets, Prinivil (lisinopril) Tablets, Vasotec (enalaprilat) IV, Vaseretic (enalapril maleate/HCTZ) Tablets, & Vasotec (enalapril maleate) Tablets | Merck Research Laboratories | NDA 20-507/S001, 19-778/S029, 19-558/S036, 19-309/S022, 19-221/S025, & 18-998/S057 | 2/17/99 | 6/22/01 | ||
| Tegretol (carbamezepine) Drug Products | Novartis Pharmaceuticals Corporation | NDA 20-234/S-017, 18-927/S-031, 18-281/S-039, 16-608/S-090 | 3/7/01 | 4/27/01 | 4/27/01 | |
| Teveten Tablets, Rx | SmithKline Beechman Pharmaceuticals | NDA 20-738/S001 | 10/28/98 | 8/13/03 | ||
| TEMODAR (Temozolomide) Capsules, Rx | Schering Corporation | NDA 21-029/S5 | 3/11/03 | 3/25/03 | 3/25/03 | |
| TEMODAR (Temozolomide) Capsules, Rx | Schering Corporation | NDA 21-029/S4 | 1/18/02 | 2/5/02 | 11/18/02 | 4/14/04 |
| TEMODAR (Temozolomide) Capsules, 250 mg;100mg; 20 mg; 5 mg, Rx | Schering Corporation | NDA 21-029 | 8/11/99 | 9/24/99 | 8/24/99 | 7/3/00 |
| Temodar Indication: treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients at first relapse who have experienced disease progression on a drug regimen containing a nitrosourea and procarbazine. | ||||||
| TEMOVATE (clobetasol propionate scalp application) Scalp Application, 0.05% | GlaxoSmithKline | NDA 19-966/S-008 | 4/3/03 | 4/18/03 | 4/18/03 | |
| TEMOVATE (clobetasol propionate gel) Gel, 0.05% | GlaxoSmithKline | NDA 20-337/S-005 | 4/2/03 | 4/18/03 | 4/18/03 | |
| TEMOVATE E (clobetasol propionate) Cream & Ointment, 0.05%, Rx | GlaxoSmithKline | NDA 19-322/SLR-018 & 19-323/SLR-019 | 4/2/03 | 4/18/03 | 4/18/03 | |
| TEMOVATE (clobetasol propionate emollient cream) Emollient, 0.05%, Rx | GlaxoSmithKline | NDA 20-340/S-006 | 4/2/03 | 4/18/03 | 4/18/03 | |
| Tenex (guanfacine hydrochloride) Tablets, 1 and 2 mg | A. H. Robbins | NDA 19-032/ S16 & S17 | 3/12/02 | 3/29/02 | 5/30/02 | |
| Tenoretic (atenolol and chlorthalidone) Tablets, 50/25 and 100/25 mg, Rx | AstraZeneca Pharmaceuticals LP | NDA 18-760/S25 | 10/30/03 | 12/2/03 | ||
| Tenoretic (atenolol and chlorthalidone) Tablets, 50/25 and 100/25 mg, Rx | AstraZeneca Pharmaceuticals LP | NDA 18-760/S-024 | 1/31/03 | 2/12/03 | ||
| Tenormin (atenolol) Tablets, 25, 50 and 100mg, Rx | AstraZeneca Pharmaceuticals LP | NDA 18-240/S-027 | 1/9/03 | 1/23/03 | ||
| Tenormin (atenolol) Tablets, 25, 50 and 100 mg, Rx & Injection, 5 mg/10ml, Rx | AstraZeneca Pharmaceuticals LP | NDA 18-240/S-028, 19-058/S16, | 11/6/03 | 11/13/03 | ||
| Tenormin (atenolol) Tablets & Injection, 5 mg, Rx | AstraZeneca Pharmaceuticals LP | NDA 19-058/S16 | 11/6/03 | |||
| Tenormin (atenolol) Injection, 5 mg, Rx | AstraZeneca Pharmaceuticals LP | NDA 19-058/S-015 | 1/22/03 | 2/25/03 | ||
| Tenormin (Atenolol) Tablets, 25, 50, & 100 mg; Tenoretic (Atenolol & Chlorthalidone) Tablets, 50/25 mg & 100/25 mg; & Tenormin (Atenolol) Injection, 5mg/10mL, Rx | Zeneca Pharmaceuticals | NDA 18-240/S026, 18-760/S023, & 19-058/S013 | 7/21/99 | 6/4/01 | ||
| Tenormin (Atenolol) Tablets, 25, 50, & 100 mg; Tenoretic (Atenolol & Chlorthalidone) Tablets, 50/25 mg; & Tenormin (Atenolol) Injection, 5mg/10mL, Rx | Zeneca Pharmaceuticals | NDA 18-240/S025, 18-760/S022, & 19-058/S012 | 4/4/00 | 6/4/01 | ||
| Tensilon (edrophonium chloride) Injection, 10 mg/ml | ICN Pharmaceuticals, Inc. | NDA 7-959/S13/S15 | 4/24/02 | 5/2/02 | ||
| Tequin (Gatifloxacin) Tablets, Injection, Rx | Bristol-Myers Squibb | NDA 21-061/S19/S20 & 21-062/S21/S22 | 1/6/04 | 1/14/04 | 1/15/04 | |
| Tequin (Gatifloxacin) Tablets & Injection, Rx | Bristol-Myers Squibb | NDA 21-061/S8/S9/S12 |
10/31/01 | 05/08/03 | ||
| Tequin (Gatifloxacin) Tablets & Injection, Rx | Bristol-Myers Squibb | NDA 21-061/S7 NDA 21-062/S8 |
10/12/01 | 6/19/02 | 6/19/02 | 6/19/02 |
| Tequin (Gatifloxacin) Tablets & Injection, Rx | Bristol-Myers Squibb | NDA 21-062/S9/S10/S12 | 10/31/01 | 05/8/03 | ||
| Tequin (Gatifloxacin) Tablets & Injection, Rx | Bristol-Myers Squibb | NDA 21-062/S6/S7 | 08/20/01 | 05/08/03 | ||
| Tequin (Gatifloxacin) Tablets & Injection, Rx | Bristol-Myers Squibb | NDA 21-061/S5/S6 |
08/20/01 | 05/08/03 | ||
| Tequin (Gatifloxacin) Tablets & Injection, Rx | Bristol-Myers Squibb | NDA 21-404, 21-405, 21-061/S-010, 21-062/S-011, 21-061/S-016 & 21-062/S-017 | 10/17/02 | 10/21/02 | 10/18/02 | |
| Tequin (Gatifloxacin) Tablets & IV, 200 and 400mg / IV-10mg/mL vials and 2mg/mL flexible containers, Rx | Bristol-Myers Squibb | NDA 21-061 NDA 21-062 |
12/17/99 | 12/27/99 | 12/27/99 | 7/18/01 |
| Tequin (Gatifloxacin) Indications: 1. Acute Bacterial Sinusitis, 2. Community Acquired Pneumonia, 3. Acute Bacterial Exacerbation Chronic Bronchitis, 4. Uncomplicated Urinary Tract Infections, 5. Complicated Urinary Tract Infections, 6. Pyelonephritis, 7. Uncomplicated Gonorrhea | ||||||
| Terazol 7 & 3 (Terconazole) Vaginal Cream, | Johnson & Johnson | NDA 19-579/S-025 & 19-964/S-020 | 9/24/03 | 9/30/03 | ||
| Terazol 7 & 3 (Terconazole) Vaginal Cream & Suppositories, Rx | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | NDA 19-579/S-016, S-020, 19-641/S-016, S-018, 19-964/S-011, S-014 | 3/11/03 | 3/25/03 | 3/25/03 | |
| Terazosin Hydrochloride Capsules, 1 mg (base), 2 mg (base), 5 mg (base), and 10 mg (base), Rx | Ranbaxy Laboratories Ltd. | ANDA 76-021 | 8/22/02 | |||
| Terazosin Hydrochloride Capsules, 1 mg (base), 2 mg (base), 5 mg (base), and 10 mg (base), Rx | Invamed Inc. | ANDA 75-667 | 7/28/00 | 11/7/00 | ||
| Terazosin Hydrochloride Capsules,1 mg (Base), 2 mg (Base), 5 mg (Base) and 10 mg (Base), Rx | Zenith Goldline Pharmaceuticals, Inc. | ANDA 75-614 | 1/30/01 | 3/5/01 | ||
| Terazosin Hydrochloride Capsules,1 mg (Base), 2 mg (Base), 5 mg (Base) and 10 mg (Base), Rx | TorPharm | ANDA 75-498 | 4/12/01 | 4/13/01 | ||
| Terazosin Hydrochloride Capsules,1 mg (Base), 2 mg (Base), 5 mg (Base) and 10 mg (Base), Rx | Mylan Technologies, Inc. | ANDA 75-384 | 12/1/00 | 3/6/01 | ||
| Terazosin Hydrochloride Capsules, 1 mg (base), 2 mg (base), 5 mg (base), and 10 mg (base), Rx | Geneva Pharmaceuticals, Inc. | ANDA 74-823 | 3/30/98 | 3/15/99 | ||
| Terazosin Hydrochloride Capsules, 1 mg (base), 2 mg (base), 5 mg (base), and 10 mg (base), Rx , Tentatively Approved Sep. 28, 1999 | Mylan Pharmaceuticals | ANDA 75-140 | 9/28/98 | 9/28/98 | 8/24/01 | |
| Terazosin Hydrochloride Capsules, 1 mg (base), 2 mg (base), 5 mg (base), and 10 mg (base), Rx , | Mylan Pharmaceuticals | ANDA 75-140 | 2/11/00 | 2/17/00 | ||
| Terazosin Hydrochloride Tablets, 1 mg (base), 2 mg (base), 5 mg (base), and 10 mg (base), Rx | Invamed, Inc. | ANDA 74-657 | 4/28/00 | 4/28/00 | 8/5/03 | |
| Terazosin Hydrochloride Tablets, 1 mg (base), 2 mg (base), 5 mg (base), and 10 mg (base), Rx , Tentatively Approved Aug. 20, 1999 | Invamed, Inc. | ANDA 74-657 | 8/20/99 | 8/24/99 | ||
Terazosin Hydrochloride Tablets, 1 mg (base), 2 mg (base), 5 mg (base) and 10 mg (base), Rx |
Zenith Goldline Pharmaceuticals, Inc. | ANDA 74-530 | 4/21/00 | 4/28/00 | 8/4/03 | |
Terazosin Hydrochloride Tablets, 1 mg (base), 2 mg (base), 5 mg (base) and 10 mg (base), Rx |
Novopharm Limited | ANDA 74-446 | 5/18/00 | 5/22/00 | 8/4/03 | |
Terazosin Hydrochloride Tablets, 1 mg (base), 2 mg (base), 5 mg (base) and 10 mg (base), Rx |
Geneva Pharmaceuticals, Inc. | ANDA 74-315 | 12/31/98 | 1/15/02 | ||
| Terbinafine Hydrochloride Tablets, 250 mg, Rx Tentatively Approved | Dr. Reddy's Laboratories | ANDA 76-390 | 12/19/03 | |||
| Terbinafine Hydrochloride Tablets, 250 mg, Rx Tentatively Approved | Teva Pharmaceuticals | ANDA 76-377 | 12/19/03 | |||
| Terbutaline Sulfate Injection, 1 mg/mL, Rx | Bedford Laboratories | ANDA 76-770 | 4/23/04 | 4/29/04 | ||
| Terbutaline Sulfate Tablets, 2.5 mg & 5 mg, Rx | Impax Laboratories | ANDA 75-877 | 6/26/01 | |||
| Terconazole Vaginal Cream, 0.8%, Rx | Taro Pharmaceuticals | ANDA 75-953 | 4/6/04 | |||
| Teril (Carbamazepine) Tablets, 200 mg, Rx | Taro Pharmaceutical | ANDA 76-525 | 9/26/03 | |||
| Teslac (testolactone) Tablets, USP, Rx | Bristol-Myers Squibb Company | NDA 16-118/S-023 | 3/21/03 | 3/25/03 | 3/25/03 | |
| TESLASCAN (mangafodipir trisodium) Injection, | Nycomed Amersham Imaging | NDA 20-652/S-003 | 7/8/02 | 7/9/02 | ||
| Testim 1% (testosterone gel), 50 mg and 100 mg | Auxilium Pharmaceuticals, Inc. | NDA 21-454 | 10/31/02 | 11/18/02 | 10/31/02 | |
| Teveten HCT (Eprosartan Mesylate/Hydrochlorothiazide) Tablets, | Biovail Technologies Ltd. | 21-268/S6 | 7/7/03 | 7/10/03 | ||
| Teveten HCT (Eprosartan Mesylate/Hydrochlorothiazide) Tablets, | Unimed Pharmaceuticals, Inc. | 21-268 | 11/1/01 | 3/5/02 | 3/5/02 | 3/5/02 |
| Teveten & HCT (Eprosartan Mesylate/Hydrochlorothiazide) Tablets, | Biovail | 20-738/S12 & 21-268/S2 | 10/16/03 | 10/17/03 | ||
| Teveten (Eprosartan Mesylate) Tablets, 300, 400 & 600 mg | SmithKline Beecham Pharmaceuticals | NDA 20-738/S004 | 5/27/99 | 7/5/01 | ||
| Thallous Chloride TI-201 Injection USP, 1 mCi/mL, Rx | Mallinckrodt Inc. | ANDA 18-150/S20 | 4/16/04 | |||
| Thallous Chloride TI-201 Injection USP, 1 mCi/mL, Rx | Mount Sinai Medical Center | ANDA 75-569 | 11/21/01 | 4/14/03 | ||
| Thalomid (thalidomide) Capsules, | Celgene Corporation | NDA 20-785/S22, S23 & S24 | 10/27/03 | 10/31/03 | 10/31/03 | |
| Thalomid (thalidomide) Capsules, | Celgene Corporation | NDA 20-785/S20 & S21 | 1/17/03 | 1/23/03 | 1/23/03 | |
|
Thalomid (thalidomide) Capsules
Thalomide Information Page |
Celgene Corporation | NDA 20-785 | 7/16/98 | 7/16/98 | 7/16/98 | 7/16/98 |
| Thalomid (thalidomide) Tablets, Rx | Celgene Corporation | NDA 20-785/S25 & S26 | 3/5/04 | 3/10/04 | ||
|
Thalomid (thalidomide) Tablets, 50 mg, Rx
Thalomide Information Page |
Celgene Corporation | NDA 20-785/S12 & S14 | 9/5/01 | 9/5/01 | 9/5/01 | |
| Theophylline in (5% dextrose) Injection, | Baxter Healthcare | NDA 18-649/S40 | 12/31/03 | 1/9/04 | 1/15/04 | |
| Theophylline Extended-Release Tablets, 400mg | Able Laboratories | ANDA 40-543 | 4/27/04 | |||
| Theophylline Extended-Release Tablets, | Able Laboratories | ANDA 40-539 | 4/27/04 | |||
| Thioridazine Hydrochloride Oral Solution USP, 100 mg/mL (Concentrate) | Pharmaceutical Associates | ANDA 40-213 | 5/29/98 | 5/29/98 | ||
| Thiotepa for Injection, 15 mg/vial & 30 mg/vial, Rx | Gensia Sicor Pharmaceuticals, Inc. | ANDA 75-730 | 4/20/01 | 4/24/01 | ||
| Thiotepa for Injection, 15 mg/vial & 30 mg/vial, Rx | aaiPharma Inc. | ANDA 75-698 | 9/20/01 | 4/14/03 | ||
| Thiotepa for Injection, 15 mg/vial, Rx | Bedford Laboratories | ANDA 75-547 | 4/2/01 | 4/6/01 | 12/17/01 | |
| Thorazine (chlorpromazine HCl) Tablets, Spansule Sustained Release Capsules, Injection, Syrup, and Suppositories. | GlaxoSmithKline | NDA 11-120/S086 | 4/3/01 | 5/2/01 | ||
| Thyro-TabsŪ (levothyroxine sodium) Tablets, USP, 25, 50, 75, 88, 100, 112, 125, 150, 175, 200, and 300 mcg strengths, Rx | Lloyd Inc. | NDA 21-116 | 10/24/02 | 10/30/02 | 10/25/02 | |
| Thyrogen (thyrotropin alfa) Injection, | Genzyme Corporation | NDA 20-898/S21 | 3/11/04 | 3/16/04 | 4/7/04 | |
| Thyrogen (thyrotropin alfa for injection) | Genzyme Corporation | NDA 20-898 | 11/30/98 | 12/1/98 | 6/19/01 | |
| Thyrogen indication: For use as an adjunctive tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow-up of patients with thyroid cancer. | ||||||
| Thyrolar (liotrix) Tablets, USP, | Forest Laboratories, Inc. | NDA 16-807/S-025 | 10/1/02 | 10/2/02 | ||
| ThyroSafe (Potassium Iodide) Tablets, 65 mg, OTC | Recip, AB | ANDA 76-350 | 9/10/02 | |||
| Tiazac/Diltiazem Hydrochloride) Capsules | Biovail | NDA 20-401 /S019 |
3/24/00 | 6/6/01 | ||
| Tiazac/Diltiazem Hydrochloride Capsules, 420 mg | Biovail | NDA 20-401 /S013 |
10/16/98 | 12/4/01 | ||
| Tiazac/Diltiazem Hydrochloride | Biovail | NDA 20-401 /S007 |
1/30/98 | 3/20/98 | ||
| Ticlid (Ticlopidine Hydrochloride) Tablets, Rx | Syntex | NDA 19-979/S019 | 6/14/00 | 6/4/01 | ||
| Ticlid (Ticlopidine Hydrochloride) Tablets, Rx | Syntex | NDA 19-979/SE1-018 | 4/18/01 | 4/8/03 | 5/9/03 | 12/18/01 |
| Ticlid Indications: adjunctive therapy with aspirin to reduce the incidence of subacute stent thrombosis in patients undergoing successful coronary stent implantation. | ||||||
| Ticlopidine Hydrochloride Tablets, 250 mg, Rx | Caraco Pharmaceutical Laboratories, Ltd. | ANDA 75-526 | 9/26/02 | |||
| Ticlopidine Hydrochloride Tablets, 250 mg. | Eon Labs | ANDA 75-326 | 8/20/99 | 8/26/99 | 12/20/01 | |
| Ticlopidine Hydrochloride Tablets, 250 mg. | Invamed, Inc. | ANDA 75-318 | 8/20/99 | 8/26/99 | 4/22/03 | |
| Ticlopidine Hydrochloride Tablets,250mg | Mylan Pharmaceuticals, Inc. | ANDA 75-316 | 11/2/99 | 12/30/99 | ||
| Ticlopidine Hydrochloride Tablets,250 mg, Rx | Danbury Pharmacal, Inc. | ANDA 75-309 | 4/26/00 | 4/28/00 | ||
| Ticlopidine Hydrochloride Tablets,250mg | Purepac Pharmaceutical | ANDA 75-253 | 8/20/99 | 8/26/99 | 4/22/03 | |
| Ticlopidine Hydrochloride Tablets,250mg | Genpharm, Inc. | ANDA 75-161 | 9/13/99 | 9/14/99 | 8/6/03 | |
|
Ticlopidine Hydrochloride Tablets, 250 mg, Rx |
Teva Pharmaceuticals USA | ANDA 75-149 | 8/20/99 | 8/26/99 | ||
| Ticlopidine Hydrochloride Tablets, 250 mg. | Apotex Corp | ANDA 75-089 | 7/1/99 | 7/2/99 | ||
| Ticlopidine Hydrochloride Tablets, 250 mg. (tentatively approved) | Novopharm N.C. Inc. | ANDA 74-994 | 10/25/99 | 12/30/99 | ||
| Tigan (Trimethobenzamide Hydrochloride) Suppositories, Injection, Rx | King Pharmaceuticals, Inc. | NDA 17-529/S-009, 17-530/S-018 | 4/30/02 | 5/2/02 | 5/24/02 | |
| Tigan (Trimethobenzamide Hydrochloride) Capsules, Rx | King Pharmaceuticals, Inc. | NDA 17-531/S-010 | 4/30/02 | 1/13/03 | 1/13/03 | |
| Tigan (Trimethobenzamide Hydrochloride) Capsules, 300 mg, Rx | King Pharmaceuticals, Inc. | NDA 17-531 | 12/13/01 | |||
| Tikosyn (dofetilide) Capsules, | Pfizer Inc. | NDA 20-931 | 10/4/99 | 10/4/99 | 8/16/01 | 4/4/02 |
| Tikosyn Indication: (1) Maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial blutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. (2)For the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. | ||||||
| Tilade (nedocromil sodium) Inhaler, | Aventis Pharmaceuticals | NDA 19-660/S17 | 2/11/04 | 3/3/04 | ||
| Timentin (sterile ticarcillin disodium/clavulanate potassium), Rx | GlaxoSmithKline | NDA 50-590/S27 | 5/17/02 | 6/3/02 | ||
| Timentin (sterile ticarcillin disodium and clavulanate potassium) Injection & Galaxy Plastic Container, Rx | GlaxoSmithKline | NDA 50-590/S40 & 50-658/S09 | 3/18/02 | 3/29/02 | ||
| Timolide Maleate (timolol maleate) Gel Forming Solution, 0.25 & 0.5%, Rx | Falcon Pharmaceuticals | NDA 20-963/S7 | 7/2/03 | |||
| Timolide (timolol maleate-hydrochlorothiazide) Tablets, 10/25 mg, Rx | Merck & Co., Inc. | NDA 18-061/S-029 | 3/4/03 | 3/10/03 | ||
| Timolol Maleate Ophthalmic Solution USP, 0.5% (base), Rx | Novex Pharma | ANDA 75-412 | 9/8/00 | 10/30/00 | 12/17/01 | |
| Timolol Maleate Ophthalmic Solution USP, 0.25% (base), Rx | Novex Pharma | ANDA 75-411 | 9/8/00 | 10/30/00 | 8/6/03 | |
| Timolol Maleate Ophthalmic Solution USP, 0.5% (base), Rx | Hi-Tech Pharmacal Co., Inc. | ANDA 75-163 | 9/10/02 | |||
| Timolol Maleate (timolol maleate) Ophthalmic Gel Forming Solution, | Falcon Pharmaceuticals, Ltd. | NDA 20-963/S7 | 7/2/03 | 7/8/03 | 7/8/03 | |
| Timolol GFS (timolol maleate ophthalmic gel forming solution, 0.25% and 0.5%), Rx | Falcon Pharmaceutical Inc. | NDA 20-963/S-5 | 2/5/01 | 04/25/03 | ||
| Timolol Indication: For the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma | ||||||
| Timolol Maleate (timolol maleate) ophthalmic gel forming solution, 0.25% and 0.5%, Rx | Alcon Laboratories | NDA 20-963 | 10/21/98 | 1/6/99 | 1/6/99 | 5/22/03 |
| Timoptic (timolol maleate) ophthalmic solution, 0.25% and 0.5%, | Merck & Co., Inc. | NDA 18-086/S60 | 12/22/03 | 12/24/03 | ||