Details for New Drug Application (NDA): 021343

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NDA 021343 describes ELIGARD KIT, which is a drug marketed by Tolmar and is included in four NDAs. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ELIGARD KIT profile page.

The generic ingredient in ELIGARD KIT is leuprolide acetate. There are twenty-two drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.

Summary for 021343

Tradename:	ELIGARD KIT
Applicant:	Tolmar
Ingredient:	leuprolide acetate
Patents:	2

Pharmacology for NDA: 021343

Mechanism of Action	Gonadotropin Releasing Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 021343

Antineoplastic Agents, Hormonal
Fertility Agents, Female

Suppliers and Packaging for NDA: 021343

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021343	NDA	TOLMAR Inc.	62935-753	62935-753-75	1 KIT in 1 CARTON (62935-753-75) * .25 mL in 1 SYRINGE (62935-754-74) * .25 mL in 1 SYRINGE (62935-755-75)
ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021343	NDA	TOLMAR Inc.	62935-756	62935-756-80	1 SYRINGE in 1 CARTON (62935-756-80) / .25 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;SUBCUTANEOUS			Strength	7.5MG
Approval Date:	Jan 23, 2002	TE:		RLD:	Yes
Patent:	11,771,841	Patent Expiration:	Dec 22, 2041	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	11,931,559	Patent Expiration:	Dec 22, 2041	Product Flag?		Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 021343

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021343-001	Jan 23, 2002	6,773,714	⤷ Subscribe
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021343-001	Jan 23, 2002	5,733,950	⤷ Subscribe
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021343-001	Jan 23, 2002	6,626,870	⤷ Subscribe
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021343-001	Jan 23, 2002	4,938,763	⤷ Subscribe
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