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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 218061

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NDA 218061 describes CETRORELIX ACETATE, which is a drug marketed by Gland, Livzon Grp, Qilu, Teva Pharms Inc, and Xiromed, and is included in five NDAs. It is available from six suppliers. Additional details are available on the CETRORELIX ACETATE profile page.

The generic ingredient in CETRORELIX ACETATE is cetrorelix acetate. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the cetrorelix acetate profile page.

Summary for 218061

Tradename:	CETRORELIX ACETATE
Applicant:	Xiromed
Ingredient:	cetrorelix acetate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;SUBCUTANEOUS			Strength	EQ 0.25MG BASE/VIAL
Approval Date:	Jun 3, 2025	TE:	AP	RLD:	No

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