Details for New Drug Application (NDA): 021488

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NDA 021488 describes ELIGARD KIT, which is a drug marketed by Tolmar Therap and is included in four NDAs. It is available from one supplier. There is one patent 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 021488

Tradename:	ELIGARD KIT
Applicant:	Tolmar Therap
Ingredient:	leuprolide acetate
Patents:	1
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 021488

Antineoplastic Agents, Hormonal
Fertility Agents, Female

Suppliers and Packaging for NDA: 021488

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021488	NDA	TOLMAR Inc.	62935-303	62935-303-30	1 KIT in 1 CARTON (62935-303-30) * .5 mL in 1 SYRINGE (62935-305-29) * .5 mL in 1 SYRINGE (62935-304-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;SUBCUTANEOUS			Strength	30MG
Approval Date:	Feb 13, 2003	TE:		RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	Oct 15, 2023	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	METHOD OF TREATING CANCER

Expired US Patents for NDA 021488

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Tolmar Therap	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021488-001	Feb 13, 2003	⤷ Try a Trial	⤷ Try a Trial
Tolmar Therap	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021488-001	Feb 13, 2003	⤷ Try a Trial	⤷ Try a Trial
Tolmar Therap	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021488-001	Feb 13, 2003	⤷ Try a Trial	⤷ Try a Trial
Tolmar Therap	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021488-001	Feb 13, 2003	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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