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 Safety Information 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… Femara (letrozole) Tablets, 2.5 mg, Novartis NDA 20-726/S8 1/17/03 1/23/03 1/23/03 | Femara (letrozole) Tablets, Novartis NDA 20-726/S-006 1/10/01 1/16/01 1/16/01 7/12/01 | Femara (letrozole) Tablets, Novartis NDA 20-726/S-005 2/26/03 3/10/03 3/11/03 | Femara Indications: First-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer. | Femara (Letrozole) Tablets, Novartis Pharma, New or Modified Indication | Femara (Letrozole) Tablets, Novartis Pharma, New or Modified Indication | Femara (letrozole) Tablets, Novartis Pharma, Labeling Revision | Femara (letrozole) Tablets, Novartis Pharma, Labeling Revision | Letrozole Tablets, Mylan Pharma, Tentative Approval | Femara (letrozole) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Letrozole Tablets, Mylan Pharmaceuticals, Inc., Approval | Letrozole Tablets, Roxane Laboratories, Inc., Tentative Approval | Femara (letrozole) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Femara (letrozole) Tablets, Novartis Pharmaceuticals Corporation, Efficacy Supplement with Clinical Data to Support | Femara (letrozole) Tablets, Novartis Pharmaceuticals Corp.. Efficacy Supplement with Clinical Data to Support | Letrozole Tablets, Fresenius Kabi Oncology, Tentative Approval | Letrozole Tablets, Accord Healthcare, Inc., Tentative Approval | Taxotere (docetaxel) Injection, Sanofi-Aventis U.S., Inc., Efficacy Supplement with Clinical Data to Suppport | Femara (letrozole) Tablets, Novartis Pharmaceuticals Corp., Labeling RevisionLetrozole Tablets, Synthon Pharmaceuticals, Inc., Tentative Approval | Letrozole Tablets, Kudco Ireland Ltd., Tentative Approval | Letrozole Tablets, Endo Pharmaceuticals, Inc., Tentative Approval | Letrozole Tablets, Indicus Pharma LLC., Approval | Letrozole Tablets, Synthon Pharmaceuticals, Inc., Approval | Letrozole Tablets, Fresenius Kabi Oncology, Approval | Letrozole Tablets, Endo Pharmaceuticals, Inc., Approval | Letrozole Tablets, Dr. Reddy’s Laboratories Ltd., Approval | Letrozole Tablets, Roxane Laboratories, Inc., Approval | Letrozole Tablets, Natco Pharma Ltd., Approval | Letrozole Tablets, Accord Healthcare, Inc., Approval | Letrozole Tablets, Impax Laboratories, Inc., Approval | Letrozole Tablets, Sun Pharmaceutical Industries Ltd., Approval | Letrozole Tablets, Kudco Ireland Ltd., Approval | Letrozole Tablets, TEVA Pharmaceuticals, Approval | Letrozole Tablets, Actavis Totowa LLC, Approval | Letrozole Tablets, Apotex Corp., Approval | Femara, letrozole, Tablet; Oral, Novartis Pharms, Approval ^ 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 | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2012 Betterchem.com