Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

FDA Approval Activities for this Drug… Eligard (Leuprolide Acetate) Injection, 30 mg, Atrix, NDA 21-488 2/13/03 2/25/03 2/14/03 5/8/03 Eligard (Leuprolide Acetate) Injection, 22.5 mg, Atrix, NDA 21-379 7/24/02 8/6/02 7/24/02 10/22/02 Eligard (Leuprolide Acetate) Injection, Atrix, NDA 21-343/S2 7/3/03 7/8/03 Eligard (Leuprolide Acetate) Injection, 7.5 mg, Sanofi-Sythelabo NDA 21-343/S-1 4/1/02 4/8/02 Eligard (Leuprolide Acetate) Injection, 7.5 mg, Atrix, NDA 21-343 1/23/02 1/31/02 1/31/02 2/12/02 Eligard Indications: Palliative treatment of advanced prostate cancer. Leuprolide Acetate Injection, 1 mg/0.2 mL, Gensia Sicor ANDA 75-471 10/25/00 11/6/00 Leuprolide Acetate Injection, 1 mg/0.2 mL, Genzyme ANDA 75-721 11/29/01 4/14/03 Leuprolide Acetate Injection, 1 mg/0.2 mL, Bedford ANDA 74-728 Lupron PED (leuprolide acetate) Depot, TAP NDA 20-263/S22 10/28/03 Lupron PED (leuprolide acetate) Depot, TAP Pharmaceutical Products, NDA 20-263/S-20 9/24/02 9/27/02 Lupron Depot (leuprolide acetate), TAP Pharmaceutical Products, NDA 19-732/S-023 & 20-517/S-013 9/9/03 9/25/03 Lupron Depot (leuprolide acetate), 7.5MG TAP Pharmaceutical Products, NDA 19-732/S-012 1/9/98 5/30/03 Lupron Depot (leuprolide acetate), 3.75 mg TAP Pharmaceutical Products, NDA 20-011/S-021 9/21/01 11/6/01 11/6/01 11/14/01 Lupron Depot-3 Month (leuprolide acetate), 11.25 mg TAP Pharmaceutical Products, NDA 20-708/S-011 9/21/01 11/25/02 9/21/01 11/14/01 Lupron Depot (leuprolide acetate) 3.75 mg & 11.25 mg TAP Holdings NDA 20-011/S-014 & 20-708/S-003 4/9/98 8/6/01 Lupron Depot (leuprolide acetate) 3-month 11.25 mg TAP Holdings NDA 20-708/S-005 2/11/99 6/22/99 Lupron Indication: Endometriosis and uterine fibroids, this specific supplement was a biopharmaceutic study comparing Lupron 3.75 mg and Lupron 11.25 mg and demonstrating comparability between the two. Drug Classification was a Standard Review. Viadur (leuprolide acetate implant), ALZA NDA 21-088/S15 8/1/03 8/15/03 Viadur (leuprolide acetate implant), ALZA NDA 21-088 3/3/00 3/7/00 3/7/00 2/28/02 Viadur Indication: palliative treatment of advanced prostate cancer. Lupron PED (leuprolide acetate) Depot, TAP LEUPROLIDE ACETATE Implant; Implantation 65MG BASE VIADUR ALZA 074728 LEUPROLIDE ACETATE Injection 1MG/0.2ML LEUPROLIDE ACETATE Bedford 075471 LEUPROLIDE ACETATE Injection 1MG/0.2ML LEUPROLIDE ACETATE Gensia Sicor 075721 LEUPROLIDE ACETATE Injection 1MG/0.2ML LEUPROLIDE ACETATE GENZYME 020263 LEUPROLIDE ACETATE Injection 11.25MG/VIAL LUPRON DEPOT-PED TAP 020708 LEUPROLIDE ACETATE Injection 11.25MG/VIAL LUPRON DEPOT-3 TAP 020263 LEUPROLIDE ACETATE Injection 15MG/VIAL LUPRON DEPOT-PED TAP 019010 LEUPROLIDE ACETATE Injection 1MG/0.2ML LUPRON TAP 020517 LEUPROLIDE ACETATE Injection 22.5MG/VIAL LUPRON DEPOT TAP 020011 LEUPROLIDE ACETATE Injection 3.75MG/VIAL LUPRON DEPOT TAP 020517 LEUPROLIDE ACETATE Injection 30MG/VIAL LUPRON DEPOT-4 TAP 019732 LEUPROLIDE ACETATE Injection 7.5MG/VIAL LUPRON DEPOT TAP 020263 LEUPROLIDE ACETATE Injection 7.5MG/VIAL LUPRON DEPOT-PED TAP 021379 LEUPROLIDE ACETATE Subcutaneous 22.5MG/VIAL ELIGARD Atrix 021488 LEUPROLIDE ACETATE Subcutaneous 30MG/VIAL ELIGARD Atrix 021343 LEUPROLIDE ACETATE Subcutaneous 7.5MG/VIAL ELIGARD Atrix Lupron (leuprolide acetate) Injection, TAP Pharmaceutical Lupron PED (leuprolide acetate) Injection, TAP Pharmaceuticals, Inc. Eligard (Leuprolide Acetate) Injection, Sanofi-Synthelabo Lupron Depot (leuprolide acetate), TAP Pharmaceutical Lupron Depot (leuprolide acetate), TAP Pharmaceutical Lupron (leuprolide acetate) Injection, TAP Pharmaceuticals, Inc.   For the latest approval information, locate this drug using this index.