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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215737
Company: TEVA PHARMS INC

Products on ANDA 215737

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CETRORELIX ACETATE	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER;SUBCUTANEOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215737

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/12/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215737Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/06/2025	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
11/06/2025	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 215737

CETRORELIX ACETATE

POWDER;SUBCUTANEOUS; EQ 0.25MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CETRORELIX ACETATE	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER;SUBCUTANEOUS	Prescription	No	AP	218740	EPIC PHARMA LLC
CETRORELIX ACETATE	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER;SUBCUTANEOUS	Prescription	No	AP	218150	GLAND
CETRORELIX ACETATE	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER;SUBCUTANEOUS	Prescription	No	AP	214540	LIVZON GRP
CETRORELIX ACETATE	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER;SUBCUTANEOUS	Prescription	No	AP	217776	QILU
CETRORELIX ACETATE	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER;SUBCUTANEOUS	Prescription	No	AP	215737	TEVA PHARMS INC
CETRORELIX ACETATE	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER;SUBCUTANEOUS	Prescription	No	AP	218061	XIROMED
CETROTIDE	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER;SUBCUTANEOUS	Prescription	Yes	AP	021197	EMD SERONO INC

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