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Last Updated: June 28, 2022

Details for New Drug Application (NDA): 021057


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NDA 021057 describes GANIRELIX ACETATE, which is a drug marketed by Amphastar Pharms Inc, Organon Usa Inc, and Sun Pharm, and is included in three 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 021057
Tradename:GANIRELIX ACETATE
Applicant:Organon Usa Inc
Ingredient:ganirelix acetate
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength250MCG/0.5ML
Approval Date:Jul 29, 1999TE:APRLD:Yes

Expired US Patents for NDA 021057

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Usa Inc GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057-001 Jul 29, 1999 See Plans and Pricing See Plans and Pricing
Organon Usa Inc GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057-001 Jul 29, 1999 See Plans and Pricing See Plans and Pricing
Organon Usa Inc GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057-001 Jul 29, 1999 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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