Last Updated: November 8, 2026

Details for New Drug Application (NDA): 075721

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NDA 075721 describes LEUPROLIDE ACETATE, which is a drug marketed by Amneal, Eugia Pharma, Genzyme, Meitheal, Ph Health, Sandoz, Somerset Theraps Llc, Sun Pharm, UBI, Zydus Pharms, and Invagen Pharms, and is included in eleven NDAs. It is available from eleven suppliers. Additional details are available on the LEUPROLIDE ACETATE profile page.

The generic ingredient in LEUPROLIDE ACETATE is leuprolide acetate. There is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.

Summary for 075721

Tradename:	LEUPROLIDE ACETATE
Applicant:	Genzyme
Ingredient:	leuprolide acetate
Patents:	0

Medical Subject Heading (MeSH) Categories for 075721

Antineoplastic Agents, Hormonal
Fertility Agents, Female

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	14MG/2.8ML (1MG/0.2ML)
Approval Date:	Nov 29, 2001	TE:		RLD:	No

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