You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 12, 2025

Details for New Drug Application (NDA): 216075

✉ Email this page to a colleague

« Back to Dashboard

NDA 216075 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 216075

Tradename:	GANIRELIX ACETATE
Applicant:	Lupin Ltd
Ingredient:	ganirelix acetate
Patents:	0

Pharmacology for NDA: 216075

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

Suppliers and Packaging for NDA: 216075

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GANIRELIX ACETATE	ganirelix acetate	INJECTABLE;INJECTION	216075	ANDA	Lupin Pharmaceuticals, Inc.	70748-274	70748-274-01	1 TRAY in 1 CARTON (70748-274-01) / 1 SYRINGE, GLASS in 1 TRAY / 1 mL in 1 SYRINGE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	250MCG/0.5ML
Approval Date:	Nov 16, 2023	TE:	AP	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.