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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 076553

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NDA 076553 describes MEDROXYPROGESTERONE ACETATE, which is a drug marketed by Amneal, Amphastar Pharms Inc, Cipla, Eugia Pharma, Hikma, Hong Kong, Sandoz, Sun Pharm, Teva Pharms Usa, Xiromed, Barr, Duramed Pharms Barr, and Upsher Smith Labs, and is included in sixteen NDAs. It is available from twenty-three suppliers. Additional details are available on the MEDROXYPROGESTERONE ACETATE profile page.

The generic ingredient in MEDROXYPROGESTERONE ACETATE is medroxyprogesterone acetate. There are twenty drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the medroxyprogesterone acetate profile page.

Summary for 076553

Tradename:	MEDROXYPROGESTERONE ACETATE
Applicant:	Hong Kong
Ingredient:	medroxyprogesterone acetate
Patents:	0

Medical Subject Heading (MeSH) Categories for 076553

Antineoplastic Agents, Hormonal
Contraceptive Agents, Female
Contraceptive Agents, Male
Contraceptives, Oral, Synthetic

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	150MG/ML
Approval Date:	Jul 28, 2004	TE:	AB	RLD:	No

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