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 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 021057

Tradename:	GANIRELIX ACETATE
Applicant:	Organon Usa Organon
Ingredient:	ganirelix acetate
Patents:	0

Pharmacology for NDA: 021057

Mechanism of Action	Gonadotropin Releasing Hormone Receptor Antagonists
Physiological Effect	Decreased GnRH Secretion

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:	RX	Dosage:	INJECTABLE;INJECTION			Strength	250MCG/0.5ML
Approval Date:	Jul 29, 1999	TE:	AP	RLD:	Yes

Expired US Patents for NDA 021057

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

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