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FDA NDA · NDA020578

ZOLADEX

goserelin

Sponsor: TERSERA

APPLICATION
NDA020578
TYPE
NDA
ORIGINAL APPROVAL
1996-01-11
LATEST ACTION
2026-05-06
ROUTE
SUBCUTANEOUS, IMPLANTATION
DOSAGE FORM
IMPLANT
MARKETING STATUS
Prescription

Products

ZOLADEX · ReferencePrescription
GOSERELIN ACETATE EQ 10.8MG BASE · IMPLANT · IMPLANTATION

Approval history

2026-05-06Labeling · Supplement 53 · standard — Letter ↗AP
2025-09-23Labeling · Supplement 51 · standard — Letter ↗AP
2021-06-17Labeling · Supplement 44 · standard — Letter ↗AP
2015-02-12Labeling · Supplement 37 · standard — Letter ↗AP
2014-10-07Labeling · Supplement 36 · standard — Label ↗AP
2013-06-18Labeling · Supplement 34 · standard — Label ↗AP
2013-06-18Labeling · Supplement 35 · standard — Label ↗AP
2011-01-14Labeling · Supplement 32 · 901 required — Label ↗AP
2009-08-31Labeling · Supplement 30 · standard — Letter ↗AP
2009-08-31Labeling · Supplement 29 · standard — Label ↗AP
2009-08-31Labeling · Supplement 28 · standard — Label ↗AP
2005-10-19Labeling · Supplement 25 · standard — Letter ↗AP
2004-06-24Labeling · Supplement 20 · standard — Letter ↗AP
2002-02-28Labeling · Supplement 16 · standard — Letter ↗AP
2002-02-05Labeling · Supplement 13 · standard — Letter ↗AP
2001-03-09Manufacturing (CMC) · Supplement 12 · standardAP
2000-10-16Manufacturing (CMC) · Supplement 11 · standardAP
2000-06-20Manufacturing (CMC) · Supplement 10 · standardAP
1999-11-03Labeling · Supplement 9 · standardAP
1999-04-14Labeling · Supplement 1 · standardAP
1999-03-04Manufacturing (CMC) · Supplement 8 · standardAP
1998-12-07Manufacturing (CMC) · Supplement 7 · standardAP
1998-09-18Manufacturing (CMC) · Supplement 6 · standardAP
1998-07-27Efficacy · Supplement 3 · standard — Review ↗AP
1998-07-16Manufacturing (CMC) · Supplement 5 · standardAP
1997-11-13Manufacturing (CMC) · Supplement 4 · standardAP
1997-06-09Manufacturing (CMC) · Supplement 2 · standardAP
1996-01-11Type 3 - New Dosage Form · Original · standard — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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