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… Zoladex (goserelin acetate) Implant, 3.6 & 10.8 mg AstraZeneca LP NDA 19-726/S-037 & 20-578/S-016 2/28/02 3/5/02 Zoladex (goserelin acetate) Implant, 3-Month 10.8 mg Depot AstraZeneca LP NDA 20-578/S13 2/5/02 4/17/02 Zoladex (goserelin acetate) Implant, 3.6 mg AstraZeneca LP NDA 19-726/S-034 2/5/02 4/17/02 8/6/01 Zoladex (goserelin acetate) Implant, 3.6 mg Zeneca NDA 19-726/S-022 4/9/98 8/6/01 Zoladex (goserelin acetate), 3.6 mg and 10.8 mg Depots Zeneca NDA 19-726/S-024 & 20-578/S-003 7/27/98 7/28/98 7/28/98 8/6/01 Zoladex indication: For the use of Zoladex (goserelin acetate) 3.6 mg and 10.8 mg Depots in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) cacinoma of the prostate. ZOLADEX (goserelin acetate implant) Depot, AstraZeneca ZOLADEX (goserelin acetate implant) Depot, AstraZeneca   For the latest approval information, locate this drug using this index.