Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218740
Company: HUMANWELL

Products on ANDA 218740

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 218740

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/29/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218740

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	218150	GLAND
CETRORELIX ACETATE	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER;SUBCUTANEOUS	Prescription	No	AP	218740	HUMANWELL
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