Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

FDA Approval Activities for this Drug… Paclitaxel Injection, 6 mg/mL, NaPro Biotherapeutics, ANDA 76-233 8/1/02 Paclitaxel Injection, 6 mg/mL, Abbott ANDA 76-131 5/8/02 Paclitaxel Injection, 6 mg/mL, Zenith Goldline ANDA 75-297 3/27/01 3/30/01 12/20/01 Paclitaxel Injection, 6 mg/mL, Zenith Goldline ANDA 75-297 10/10/00 10/30/00 Paclitaxel Injection, 30 mg/5mL (6 mg/mL), Mylan ANDA 75-278 7/23/01 Paclitaxel Injection, 30 mg/5mL (6 mg/mL), Mylan ANDA 75-278 9/19/00 10/30/00 Paclitaxel Injection, 6 mg/mL, Zenith Goldline ANDA 75-227 10/10/00 Paclitaxel Injection, 6 mg/mL, Bedford ANDA 75-190 7/27/01 4/9/03 Paclitaxel Injection, 6 mg/mL, Baker Norton ANDA 75-184 9/15/00 10/31/00 8/6/03 Paclitaxel Injection, 6 mg/mL, Baker Norton ANDA 75-184 Taxol (paclitaxel) Injection, Bristol-Myers Squibb NDA 20262/S041 3/5/03 3/26/03 Taxol (paclitaxel) Injection, 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, 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, Bristol-Myers Squibb NDA 20-262 / S-031 1/8/99 7/6/00 Taxol (paclitaxel) Injection, Bristol-Myers Squibb NDA 20-262 / S-033 10/25/99 12/30/99 12/30/99 Taxol (paclitaxel) Injection, 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. PACLITAXEL Injection 6MG/ML PACLITAXEL Abbott 075184 PACLITAXEL Injection 6MG/ML PACLITAXEL BAKER NORTON 075190 PACLITAXEL Injection 6MG/ML PACLITAXEL Bedford 020262 PACLITAXEL Injection 6MG/ML TAXOL BRISTOL MYERS SQUIBB 075297 PACLITAXEL Injection 6MG/ML PACLITAXEL Ivax 075278 PACLITAXEL Injection 6MG/ML PACLITAXEL Mylan 076233 PACLITAXEL Injection 6MG/ML PACLITAXEL NAPRO   For the latest approval information, locate this drug using this index.