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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

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