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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 217437

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NDA 217437 describes LEUPROLIDE ACETATE, which is a drug marketed by Amneal, Eugia Pharma, Genzyme, Meitheal, Ph Health, Rk Pharma, Sandoz, Sun Pharm, UBI, Zydus Pharms, and Invagen Pharms, and is included in eleven NDAs. It is available from twelve suppliers. Additional details are available on the LEUPROLIDE ACETATE profile page.

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

Summary for 217437

Tradename:	LEUPROLIDE ACETATE
Applicant:	Ph Health
Ingredient:	leuprolide acetate
Patents:	0

Medical Subject Heading (MeSH) Categories for 217437

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:	Jun 9, 2025	TE:		RLD:	No

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