Skip to content

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.

Skip to content

Zoladex

Manages locally confined carcinoma of the prostate Palliative treatment of advanced…. NDA 19726, held by Tersera. Goserelin Acetate.

As of Nov 13, 2026, NDA 19726 (Zoladex), held by Tersera, was first approved by FDA on Dec 29, 1989, with 46 approved supplements and 0 published complete response letters.

First approved: Dec 29, 1989
Review: Standard
Supplements approved: 46
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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 Palliative treatment of advanced carcinoma of the prostate The management of endometriosis Use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding Use in the palliative treatment of advanced breast cancer in pre- and perimenopausal women 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 47 submissions below


Jul 27, 1998	Supplement 24Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
Apr 9, 1998	Supplement 22Efficacy (new indication or use) · Standard review	Approved	Review
Jun 27, 1997	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Review
Feb 2, 1993	Supplement 5Efficacy (new indication or use)	Approved	None posted
Dec 29, 1989	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
ZoladexEQ 3.6MG BASE · implant;implantation	Goserelin Acetate	RxReference drug

All 47 submissions, including labeling and manufacturing supplements


May 6, 2026	Supplement 76Labeling · Standard review	Approved	Label Letter
Sep 23, 2025	Supplement 74Labeling · Standard review	Approved	Label Letter
Mar 16, 2023	Supplement 69Labeling · Standard review	Approved	Label Letter
Jun 17, 2021	Supplement 66Labeling · Standard review	Approved	Letter
Jul 19, 2016	Supplement 60Manufacturing · Standard review	Approved	None posted
Feb 12, 2015	Supplement 59Labeling · Standard review	Approved	Letter Label
Oct 7, 2014	Supplement 58Labeling · Standard review	Approved	Letter Label
Jun 18, 2013	Supplement 57Labeling · Standard review	Approved	Letter Label
Jun 18, 2013	Supplement 56Labeling · Standard review	Approved	Letter Label
Jan 14, 2011	Supplement 54Labeling	Approved	Letter Label
Aug 31, 2009	Supplement 52Labeling · Standard review	Approved	Letter Label
Aug 31, 2009	Supplement 51Labeling · Standard review	Approved	Letter Label
Aug 31, 2009	Supplement 50Labeling · Standard review	Approved	Letter Label
May 7, 2008	Supplement 49Manufacturing	Approved	None posted
Oct 19, 2005	Supplement 46Labeling · Standard review	Approved	Letter
Jun 24, 2004	Supplement 42Labeling · Standard review	Approved	Letter
Sep 13, 2002	Supplement 38Manufacturing · Standard review	Approved	None posted
Feb 28, 2002	Supplement 37Labeling · Standard review	Approved	Letter
Feb 5, 2002	Supplement 34Labeling · Standard review	Approved	Letter Review
Jan 29, 2002	Supplement 36Manufacturing · Standard review	Approved	None posted
Oct 16, 2000	Supplement 33Manufacturing · Standard review	Approved	None posted
Dec 10, 1999	Supplement 31Manufacturing · Standard review	Approved	None posted
Nov 3, 1999	Supplement 30Labeling · Standard review	Approved	None posted
Jan 20, 1999	Supplement 28Manufacturing · Standard review	Approved	None posted
Dec 7, 1998	Supplement 27Manufacturing · Standard review	Approved	None posted
Sep 18, 1998	Supplement 26Manufacturing · Standard review	Approved	None posted
Jul 27, 1998	Supplement 24Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
Apr 9, 1998	Supplement 22Efficacy (new indication or use) · Standard review	Approved	Review
Nov 13, 1997	Supplement 23Manufacturing · Standard review	Approved	None posted
Aug 20, 1997	Supplement 21Manufacturing · Standard review	Approved	None posted
Jun 27, 1997	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Review
Jun 9, 1997	Supplement 20Manufacturing · Standard review	Approved	None posted
Feb 4, 1997	Supplement 19Labeling · Standard review	Approved	None posted
Feb 14, 1996	Supplement 16Manufacturing · Standard review	Approved	None posted
Dec 18, 1995	Supplement 17Labeling · Standard review	Approved	None posted
May 12, 1995	Supplement 15Manufacturing · Standard review	Approved	None posted
Oct 31, 1994	Supplement 13Manufacturing · Standard review	Approved	None posted
Apr 7, 1994	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 29, 1994	Supplement 8Labeling	Approved	None posted
Jan 6, 1994	Supplement 11Labeling · Standard review	Approved	None posted
Jan 6, 1994	Supplement 10Manufacturing · Standard review	Approved	None posted
Feb 2, 1993	Supplement 5Efficacy (new indication or use)	Approved	None posted
Apr 28, 1992	Supplement 7Labeling	Approved	None posted
Aug 15, 1991	Supplement 3Manufacturing · Standard review	Approved	None posted
Feb 26, 1991	Supplement 2Labeling	Approved	None posted
Jan 17, 1991	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 29, 1989	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 19726
Drugs@FDA: Overview at FDA
Company: Tersera

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