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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. | LUPRON (leuprolide acetate) Injection, TAP Pharma, Labeling Revision | ELIGARD (leuprolide acetate) injectable suspension, Atrix Laboratories, Approval | VIADUR (leuprolide acetate) implant, Alza Corp., Labeling Revision | VIADUR (leuprolide acetate implant), Alza Corp., Labeling Revision | Lupron Depot (leuprolide acetate) Suspension, TAP Pharma, Control Supplement & Labeling Revision | Lupron Depot (leuprolide acetate) Suspension, TAP Pharma, Control Supplement & Labeling Revision | Lupron (leuprolide acetate) Injection, TAP Pharma, Control Supplement | Lupron Depot (leuprolide acetate) Suspension, TAP Pharma, Control Supplement & Labeling Revision | Lupron Depot (leuprolide acetate) Suspension, TAP Pharma, Control Supplement & Labeling Revision | Lupron Depot (leuprolide acetate) Suspension, TAP Pharma, Control Supplement & Labeling Revision | Lupron (leuprolide acetate) Injection,(pediatric) and Lupron Depot-Ped (leuprolide acetate depot suspension), Tap Pharma, Labeling Revision | ELIGARD (leuprolide acetate for injectable suspension), QLT, Inc., Package Change | Lupron (leuprolide acetate) Injection, Tap Pharma, Labeling Revision | Lupron Depot (leuprolide acetate 3.75mg) Depot Suspension, Tap Pharma, Labeling Revision | Lupron Depot (leuprolide acetate11.25mg) Depot Suspension, Tap Pharma, Labeling Revision | ELIGARD (leuprolide acetate 45mg) for Injectable Suspension, Sanofi-Aventis, Labeling Revision | ELIGARD (leuprolide acetate 30mg) for Injectable Suspension, Sanofi-Aventis, Labeling Revision | ELIGARD (leuprolide acetate 22.5mg) for Injectable Suspension, Sanofi-Aventis, Labeling Revision | ELIGARD (leuprolide acetate 7.5mg) for Injectable Suspension, Sanofi-Aventis, Labeling Revision
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