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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 216075


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NDA 216075 describes GANIRELIX ACETATE, which is a drug marketed by Amphastar Pharms Inc, Gland Pharma Ltd, Lupin Ltd, Meitheal, and Organon Usa Organon, and is included in five NDAs. It is available from seven 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. Eight 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
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:RXDosage:INJECTABLE;INJECTIONStrength250MCG/0.5ML
Approval Date:Nov 16, 2023TE:APRLD:No

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