← FDA DRUG APPROVALS

FDA NDA · NDA021057

GANIRELIX ACETATE

Sponsor: ORGANON USA ORGANON

APPLICATION
NDA021057
TYPE
NDA
ORIGINAL APPROVAL
1999-07-29
LATEST ACTION
2024-09-23
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

GANIRELIX ACETATE · ReferencePrescription
GANIRELIX ACETATE 250MCG/0.5ML · INJECTABLE · INJECTION

Approval history

2024-09-23Labeling · Supplement 24 · standard — Label ↗AP
2023-08-14Labeling · Supplement 19 · standard — Letter ↗AP
2023-08-14Labeling · Supplement 17 · standard — Letter ↗AP
2023-08-14Labeling · Supplement 21 · standard — Letter ↗AP
2023-08-14Labeling · Supplement 14 · standard — Letter ↗AP
2020-10-22Labeling · Supplement 20 · standard — Label ↗AP
2016-05-03Manufacturing (CMC) · Supplement 15 · priorityAP
2016-03-10Manufacturing (CMC) · Supplement 9 · priorityAP
2015-01-12Manufacturing (CMC) · Supplement 13 · priorityAP
2014-12-19Labeling · Supplement 10 · unknown — Letter ↗AP
2008-06-30Labeling · Supplement 7 · standard — Label ↗AP
2002-12-20Manufacturing (CMC) · Supplement 3 · priorityAP
2001-06-07Manufacturing (CMC) · Supplement 1 · priorityAP
2001-05-15Labeling · Supplement 2 · standardAP
1999-07-29Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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