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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 212613

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NDA 212613 describes GANIRELIX ACETATE, which is a drug marketed by Amphastar Pharms Inc, Gland, Lupin Ltd, Meitheal, Organon Usa Organon, Qilu, and Tris Pharma Inc, and is included in seven NDAs. It is available from eight suppliers. Additional details are available on the GANIRELIX ACETATE profile page.

The generic ingredient in GANIRELIX ACETATE is ganirelix acetate. There are four drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ganirelix acetate profile page.

Summary for 212613

Tradename:	GANIRELIX ACETATE
Applicant:	Amphastar Pharms Inc
Ingredient:	ganirelix acetate
Patents:	0

Pharmacology for NDA: 212613

Mechanism of Action	Gonadotropin Releasing Hormone Receptor Antagonists
Physiological Effect	Decreased GnRH Secretion

Suppliers and Packaging for NDA: 212613

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GANIRELIX ACETATE	ganirelix acetate	INJECTABLE;INJECTION	212613	ANDA	Amphastar Pharmaceuticals, Inc.	0548-5001	0548-5001-00	1 SYRINGE in 1 CARTON (0548-5001-00) / .5 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	250MCG/0.5ML
Approval Date:	Apr 7, 2022	TE:	AP	RLD:	No

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