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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 218855


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NDA 218855 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 nine 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. Ten suppliers are listed for this compound. Additional details are available on the ganirelix acetate profile page.
Summary for 218855
Tradename:GANIRELIX ACETATE
Applicant:Qilu
Ingredient:ganirelix acetate
Patents:0
Pharmacology for NDA: 218855
Mechanism of ActionGonadotropin Releasing Hormone Receptor Antagonists
Physiological EffectDecreased GnRH Secretion
Suppliers and Packaging for NDA: 218855
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 218855 ANDA Qilu Pharmaceutical Co., Ltd. 67184-0574 67184-0574-1 1 BLISTER PACK in 1 CARTON (67184-0574-1) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS
GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 218855 ANDA Mullan Pharmaceutical Inc. 83301-0082 83301-0082-1 1 SYRINGE, GLASS in 1 CARTON (83301-0082-1) / .5 mL in 1 SYRINGE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength250MCG/0.5ML
Approval Date:Apr 23, 2025TE:APRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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