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FDA ANDA · ANDA215737

CETRORELIX ACETATE

Sponsor: TEVA PHARMS INC

APPLICATION
ANDA215737
TYPE
ANDA
ORIGINAL APPROVAL
2022-08-12
LATEST ACTION
2025-11-06
ROUTE
SUBCUTANEOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued

Products

CETRORELIX ACETATEDiscontinued
CETRORELIX ACETATE EQ 0.25MG BASE/VIAL · POWDER · SUBCUTANEOUS

Approval history

2025-11-06Labeling · Supplement 3 · standardAP
2025-11-06Labeling · Supplement 4 · standardAP
2022-08-12UNKNOWN · Original · standard — Letter ↗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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