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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
  
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