Last Updated: September 24, 2026

Details for New Drug Application (NDA): 075471

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NDA 075471 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 twelve 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. Seventeen suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.

Summary for 075471

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

Medical Subject Heading (MeSH) Categories for 075471

Antineoplastic Agents, Hormonal
Fertility Agents, Female

Suppliers and Packaging for NDA: 075471

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEUPROLIDE ACETATE	leuprolide acetate	SOLUTION;SUBCUTANEOUS	075471	ANDA	Meitheal Pharmaceuticals Inc	71288-569	71288-569-90	1 KIT in 1 CARTON (71288-569-90) * 1 VIAL, MULTI-DOSE in 1 CARTON (71288-565-03) / 2.8 mL in 1 VIAL, MULTI-DOSE * .5 mL in 1 PACKET (71288-350-91)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	14MG/2.8ML (1MG/0.2ML)
Approval Date:	Oct 25, 2000	TE:	AP	RLD:	No

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