Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 | Paclitaxel Injection, SuperGen, Inc., Approval | Paclitaxel Injection, Dabur Oncology, Approval | ABRAXANE Injectable Suspension, Abraxis BioScience, Efficacy Supp. w/Clinical Data | Paclitaxel Injection, EBEWE Pharma, Approval | Paclitaxel Injection, PLIVA, Approval | Abraxane (paclitaxel) I.V. Suspension, Abraxis Bioscience, Inc., Labeling Revision ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com