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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,   For the latest approval information, locate this drug using this index.