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Last Updated: July 30, 2021

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Details for New Drug Application (NDA): 204246

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NDA 204246 describes GANIRELIX ACETATE, which is a drug marketed by Organon Usa Inc and Sun Pharm and is included in two NDAs. It is available from two 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. Two suppliers are listed for this compound. Additional details are available on the ganirelix acetate profile page.
Summary for 204246
Applicant:Sun Pharm
Ingredient:ganirelix acetate
Pharmacology for NDA: 204246
Suppliers and Packaging for NDA: 204246
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 204246 ANDA FERRING PHARMACEUTICALS INC. 55566-1000 55566-1000-1 1 BLISTER PACK in 1 CARTON (55566-1000-1) > 1 SYRINGE in 1 BLISTER PACK > .5 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength250MCG/0.5ML
Approval Date:Nov 30, 2018TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson

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