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Details for New Drug Application (NDA): 021057

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NDA 021057 describes GANIRELIX ACETATE, which is a drug marketed by Organon Usa Inc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. 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. One supplier is listed for this compound. Additional details are available on the ganirelix acetate profile page.

Summary for NDA: 021057

Tradename:
GANIRELIX ACETATE
Applicant:
Organon Usa Inc
Ingredient:
ganirelix acetate
Patents:1

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 USA Inc. 0052-0301 0052-0301-51 1 BLISTER PACK in 1 CARTON (0052-0301-51) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS
GANIRELIX ACETATE
ganirelix acetate
INJECTABLE;INJECTION 021057 NDA Organon USA Inc. 0052-0301 0052-0301-81 1 BLISTER PACK in 1 CARTON (0052-0301-81) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 250MCG BASE/0.5ML
Approval Date:Jul 29, 1999TE:RLD:Yes
Patent:6,653,286Patent Expiration:Jun 16, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:INHIBITION OF PREMATURE LH SURGES IN WOMEN UNDERGOING CONTROLLED OVARIAN HYPERSTIMULATION WITH FSH

Expired Orange Book Patents for NDA: 021057

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Usa Inc
GANIRELIX ACETATE
ganirelix acetate
INJECTABLE;INJECTION021057-001Jul 29, 19994,801,577► subscribe
Organon Usa Inc
GANIRELIX ACETATE
ganirelix acetate
INJECTABLE;INJECTION021057-001Jul 29, 19995,767,082► subscribe
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