Manages locally confined carcinoma of the prostate. NDA 20578, held by Tersera. Goserelin Acetate.
As of Nov 14, 2026, NDA 20578 (Zoladex), held by Tersera, was first approved by FDA on Jan 11, 1996, with 27 approved supplements and 0 published complete response letters.
ZOLADEX is a Gonadotropin Releasing Hormone (GnRH) agonist indicated for: Use in combination with flutamide for the management of locally confined carcinoma of the prostate Use as palliative treatment of advanced carcinoma of the prostate 1.1 Stage B2-C Prostatic Carcinoma ZOLADEX is indicated for use in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate. Treatment with ZOLADEX and flutamide should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy. 1.2 Prostatic Carcinoma ZOLADEX is indicated in the palliative treatment of advanced carcinoma of the prostate.
| Jul 27, 1998 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Jan 11, 1996 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| ZoladexEQ 10.8MG BASE · implant;implantation | Goserelin Acetate | RxReference drug |
| May 6, 2026 | Supplement 53Labeling · Standard review | Approved | |
| Sep 23, 2025 | Supplement 51Labeling · Standard review | Approved | |
| Jun 17, 2021 | Supplement 44Labeling · Standard review | Approved | |
| Feb 12, 2015 | Supplement 37Labeling · Standard review | Approved | |
| Oct 7, 2014 | Supplement 36Labeling · Standard review | Approved | |
| Jun 18, 2013 | Supplement 34Labeling · Standard review | Approved | |
| Jun 18, 2013 | Supplement 35Labeling · Standard review | Approved | |
| Jan 14, 2011 | Supplement 32Labeling | Approved | |
| Aug 31, 2009 | Supplement 28Labeling · Standard review | Approved | |
| Aug 31, 2009 | Supplement 29Labeling · Standard review | Approved | |
| Aug 31, 2009 | Supplement 30Labeling · Standard review | Approved | |
| Oct 19, 2005 | Supplement 25Labeling · Standard review | Approved | |
| Jun 24, 2004 | Supplement 20Labeling · Standard review | Approved | |
| Feb 28, 2002 | Supplement 16Labeling · Standard review | Approved | |
| Feb 5, 2002 | Supplement 13Labeling · Standard review | Approved | |
| Mar 9, 2001 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Oct 16, 2000 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Jun 20, 2000 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Nov 3, 1999 | Supplement 9Labeling · Standard review | Approved | None posted |
| Apr 14, 1999 | Supplement 1Labeling · Standard review | Approved | None posted |
| Mar 4, 1999 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Dec 7, 1998 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Sep 18, 1998 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jul 27, 1998 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Jul 16, 1998 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Nov 13, 1997 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jun 9, 1997 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1996 | Original applicationNew dosage form · Standard review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
