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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 012541

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NDA 012541 describes DEPO-PROVERA, which is a drug marketed by Pfizer and is included in two NDAs. It is available from three suppliers. Additional details are available on the DEPO-PROVERA profile page.

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

Summary for 012541

Tradename:	DEPO-PROVERA
Applicant:	Pfizer
Ingredient:	medroxyprogesterone acetate
Patents:	0

Medical Subject Heading (MeSH) Categories for 012541

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

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	400MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Expired US Patents for NDA 012541

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	DEPO-PROVERA	medroxyprogesterone acetate	INJECTABLE;INJECTION	012541-002	Approved Prior to Jan 1, 1982	⤷ Get Started Free	⤷ Get Started Free
Pfizer	DEPO-PROVERA	medroxyprogesterone acetate	INJECTABLE;INJECTION	012541-003	Approved Prior to Jan 1, 1982	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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