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… Alendronate Sodium Tablets, 35 & 70 mg, Barr, ANDA 76-184 4/23/02 | Alendronate Sodium Tablets, 5, 10 & 40 mg, Ivax ANDA 75-711 7/24/02 | Alendronate Sodium Tablets, 5, 10, 35, 40 & 70 mg (base), Teva ANDA 75-710 | Fosamax (alendronate sodium) Solution, Merck NDA 21-575 9/17/03 9/25/03 9/25/03 | Fosamax (alendronate sodium) Tablets, Merck & Co., NDA 20-560/S-037 3/24/03 3/26/03 | Fosamax (alendronate sodium) Tablets, Merck & Co., NDA 20-560/S-036 8/5/02 8/12/02 8/5/02 | Fosamax (alendronate sodium) Tablets, Merck & Co., NDA 20-560/S-033 8/13/02 8/14/02 | Fosamax (alendronate sodium) Tablets, Merck & Co., NDA 20-560/S-031 7/25/02 7/26/02 | Fosamax (alendronate sodium) Tablets, Merck & Co., NDA 20-560/S-028 9/16/02 9/20/02 9/17/02 | Fosamax Tablets,10mg, Merck Research NDA 20-560/S-012 6/16/99 6/17/99 6/17/99 6/19/00 | Fosamax Indication: for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density. | Fosamax Tablets, 5mg, 10mg & 40 mg, Merck Research NDA 20-560/S-013 6/8/99 6/19/00 | Fosamax (alendronate sodium) Tablets,10mg, Merck Research NDA 20-560/S-018 11/24/99 12/29/99 4/24/03 | Fosamax (alendronate sodium) Tablets,10mg, Merck Research NDA 20-560/S-015 11/24/99 12/29/99 4/24/03 | Fosamax (alendronate sodium) Tablets,35 & 70mg, Merck Research NDA 20-560/S-021 & S-22 10/20/00 10/30/00 8/16/01 | Fosamax Indication: for the prevention (S-021) and treatment (S-022) of postmenopausal osteoporosis, respectively. | Fosamax (alendronate sodium) Tablets,10mg, Merck Research NDA 20-560/S-023 9/29/00 10/10/00 | Fosamax Indication: Treatment to increase bone mass in men with osteoporosis. | Fosamax (alendronate sodium) Tablets,70mg, Merck & Co., NDA 20-560/S-024 & S-025 1/31/01 2/8/01 2/8/01 | Fosamax (alendronate sodium) Tablets, Merck & Co., NDA 20-560/S40 9/17/03 9/29/03 | Fosamax Indication: Treatment to increase bone mass in men with osteoporosis. Alendronate Sodium Tablets, Mylan Pharmaceuticals, Fosamax (alendronate sodium) Tablets & Oral Solution, Merck Fosamax (alendronate sodium) Tablets & Oral Solution, Merck Fosamax (alendronate sodium) Tablets & Oral Solution, Merck Alendronate Sodium Tablets, Watson Laboratories | Fosamax Plus D (alendronate sodium vitamin D3) Tablets, Merck & Co., Approval | Fosamax (alendronate sodium) Tablets, Merck & Co., Labeling Revision | Fosamax (alendronate sodium) Oral Solution, Merck & Co., Labeling Revision | Fosamax Plus D (alendronate sodium Vitamin D3) Tablets, Merck & Co., Labeling Revsion | Fosamax (alendronate sodium) Tablets, Merck & Co., New or Modified Indication | Fosamax (alendronate sodium) Oral Solution, Merck & Co., Labeling Revision | Fosamax (alendronate sodium) Tablets, Merck & Co., Labeling Revision | Fosamax Plus D (alendronate sodium I.U. Vitamin D) Tablets, Merck & Co., Labeling Revision | Fosamax Plus D (alendronate sodium/vitamin D3) Tablets, Merck & Co., New Dosage Regimen | Alendronate Sodium Tablets, Teva Pharma, Approval | Alendronate Sodium Tablets, Barr Labs, Approval | Alendronate Sodium Tablets, Apotex, Tentative Approval | Alendronate Sodium Tablets, Apotex, Inc., Approval | Alendronate Sodium Tablets, Aurobindo Pharma, Ltd., Approval | Alendronate Sodium Tablets, Barr Laboratories, Inc., Labeling | Alendronate Sodium Tablets, Cobalt Laboratories, Inc., Approval | Alendronate Sodium Tablets, Dr. Reddy's Laboratories, Ltd., Approval | Alendronate Sodium Tablets, Dr. Reddy's Laboratories, Ltd., Approval | Alendronate Sodium Tablets, Mylan Pharmaceuticals, Inc., Approval | Alendronate Sodium Tablets, Watson Laboratories, Inc., Approval | Alendronate Sodium Tablets, Sun Pharmaceutical Industries, Ltd., Approval | Fosamax (alendronate sodium) Oral Solution, Merck & Co., Inc., Packaging Addition | Fosamax (alendronate sodium) Tablets, Merck & Co., Inc., Packaging Addition | Fosamax Plus D (alendronate sodium and cholecalciferol) Tablets, Merck & Co., Inc., Packaging Addition | Alendronate Sodium Tablets, Sandoz, Inc., Approval | Alendronate Sodium Tablets, AustarPharma, LLC, Approval | Alendronate Sodium Tablets, Cadista Pharmaceuticals Inc., Approval | Fosamax (alendronate sodium) Tablets, Merck & Co., Inc., Labeling Revision | Fosamax (alendronate sodium) Oral Solution, Merck & Co., Inc., Labeling Revision | Fosamax Plus D (alendronate sodium and cholecalciferol) Tablets, Merck & Co., Inc., Labeling Revision | Fosamax (alendronate sodium) Tablets, Merck Sharp & Dohme Corp, Labeling Revision | Fosamax (alendronate sodium) Oral Solution, Merck Sharp & Dohme Corp, Labeling Revision | Fosamax Plus D (alendronate sodium and cholecalciferol) Tablets, Merck Sharp & Dohme Corp, Labeling Revision | Fosamax Plus D (alendronate sodium and cholecalciferol) Tablets, Merck Sharp & Dohme Corp., Labeling Revision | Fosamax (alendronate sodium) Tablets, Merck Sharp & Dohme Corp., Labeling Revision | Fosamax (alendronate sodium) Oral Solution, Merck Sharp & Dohme Corp., 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 | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2012 Betterchem.com