FDA Approval Activities for this Drug…

Aredia (pamidronate disodium) Injection, Novartis NDA 20-036 4/15/94 4/30/03 Aredia (pamidronate disodium) Injection, Novartis NDA 20-036/s026 7/12/02 7/15/02 Aredia (pamidronate disodium) Injection, Novartis NDA 20-036/s024 8/20/01 11/5/01 11/5/01 11/14/01 Aredia (pamidronate disodium for injection), Novartis NDA 20-036/S20 10/9/03 10/16/03 Aredia (pamidronate disodium for injection), Novartis NDA 20-036/s015 9/22/98 7/3/00 7/3/00 Aredia (pamidronate disodium for injection), Novartis NDA 20-036/s016 9/22/98 7/19/00 7/19/00 Aredia (pamidronate disodium for injection), Novartis NDA 20-927 Pamidronate Disodium Injection, 3 & 9 mg/mL, American Pharmaceutical Partners, ANDA 76-207 5/17/02 Pamidronate Disodium Injection, 3 & 9 mg/mL, Gensia Sicor ANDA 76-153 3/27/02 4/10/03 Pamidronate Disodium Injection, 3 & 9 mg/mL, Gensia Sicor ANDA 76-153 2/28/02 4/11/03 Pamidronate Disodium Injection, Bedford NDA 21-113 3/4/02 3/12/02 5/30/02 5/30/02 Pamidronate Disodium Injection, Faulding Pharmaceutical Co. ANDA 75-841 6/27/02 Pamidronate Disodium Injection, 30 mg/vial, & 90 mg/vial, American Pharmaceutical Partners ANDA 75-773 5/6/02 Pamidronate Disodium Injection, 30 mg/vial, & 90 mg/vial, American Pharmaceutical Partners ANDA 75-773 8/24/01 4/15/03 Pamidronate Disodium Injection, 30 mg/vial, & 90 mg/vial, Aesgen, ANDA 75-594 5/6/02 Pamidronate Disodium Injection, 30 mg/vial, & 90 mg/vial, Aesgen, ANDA 75-594 11/28/01 4/14/03 Pamidronate Disodium Injection, 30 mg/vial, & 90 mg/vial, Bedford ANDA 75-290 PAMIDRONATE DISODIUM Injection 30MG/VIAL PAMIDRONATE DISODIUM AESGEN 075594 PAMIDRONATE DISODIUM Injection 90MG/VIAL PAMIDRONATE DISODIUM AESGEN 076207 PAMIDRONATE DISODIUM Injection 30MG /10ML(3MG/ML) PAMIDRONATE DISODIUM AM PARTNERS 075773 PAMIDRONATE DISODIUM Injection 30MG/VIAL PAMIDRONATE DISODIUM AM PARTNERS 076207 PAMIDRONATE DISODIUM Injection 90MG /10ML(9MG/ML) PAMIDRONATE DISODIUM AM PARTNERS 075773 PAMIDRONATE DISODIUM Injection 90MG/VIAL PAMIDRONATE DISODIUM AM PARTNERS 021113 PAMIDRONATE DISODIUM Injection 30MG /10ML(3MG/ML) PAMIDRONATE DISODIUM Bedford 075290 PAMIDRONATE DISODIUM Injection 30MG/VIAL PAMIDRONATE DISODIUM Bedford 021113 PAMIDRONATE DISODIUM Injection 90MG /10ML(9MG/ML) PAMIDRONATE DISODIUM Bedford 075290 PAMIDRONATE DISODIUM Injection 90MG/VIAL PAMIDRONATE DISODIUM Bedford 075841 PAMIDRONATE DISODIUM Injection 30MG /10ML(3MG/ML) PAMIDRONATE DISODIUM Faulding 075841 PAMIDRONATE DISODIUM Injection 60MG /10ML(6MG/ML) PAMIDRONATE DISODIUM Faulding 075841 PAMIDRONATE DISODIUM Injection 90MG /10ML(9MG/ML) PAMIDRONATE DISODIUM Faulding 076153 PAMIDRONATE DISODIUM Injection 30MG /10ML(3MG/ML) PAMIDRONATE DISODIUM Gensia Sicor 076153 PAMIDRONATE DISODIUM Injection 90MG /10ML(9MG/ML) PAMIDRONATE DISODIUM Gensia Sicor 020036 PAMIDRONATE DISODIUM Injection 30MG/VIAL AREDIA NOVARTIS 020036 PAMIDRONATE DISODIUM Injection 60MG/VIAL AREDIA NOVARTIS 020036 PAMIDRONATE DISODIUM Injection 90MG/VIAL AREDIA NOVARTIS Aredia (pamidronate disodium) Injection, Novartis | Pamidronate Disodium Injection, Bedford Laboratories, Manufacturing Change or AdditionPharmaceuticals Corporation | Aredia (pamidronate disodium) injection, Novartis Pharma, Labeling Revision

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