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Last Updated: March 28, 2024

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, Gland Pharma Ltd, Lupin Ltd, Meitheal, and Organon Usa Organon, and is included in five NDAs. It is available from six 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. Seven 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 Organon
Ingredient:ganirelix acetate
Patents:0
Pharmacology for NDA: 021057
Suppliers and Packaging for NDA: 021057
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057 NDA Organon LLC 78206-138 78206-138-01 1 BLISTER PACK in 1 CARTON (78206-138-01) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS
GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057 NDA Organon LLC 78206-138 78206-138-02 1 BLISTER PACK in 1 CARTON (78206-138-02) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS

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 Organon GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057-001 Jul 29, 1999 ⤷  Try a Trial ⤷  Try a Trial
Organon Usa Organon GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057-001 Jul 29, 1999 ⤷  Try a Trial ⤷  Try a Trial
Organon Usa Organon GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057-001 Jul 29, 1999 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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