Last Updated: May 14, 2026

Details for New Drug Application (NDA): 011839


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NDA 011839 describes PROVERA, which is a drug marketed by Pfizer and is included in one NDA. It is available from two suppliers. Additional details are available on the PROVERA profile page.

The generic ingredient in 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 011839
Tradename:PROVERA
Applicant:Pfizer
Ingredient:medroxyprogesterone acetate
Patents:0
Pharmacology for NDA: 011839
Medical Subject Heading (MeSH) Categories for 011839
Antineoplastic Agents, Hormonal
Contraceptive Agents, Female
Contraceptive Agents, Male
Contraceptives, Oral, Synthetic
Suppliers and Packaging for NDA: 011839
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROVERA medroxyprogesterone acetate TABLET;ORAL 011839 NDA Pharmacia & Upjohn Company LLC 0009-0051 0009-0051-01 100 TABLET in 1 BOTTLE (0009-0051-01)
PROVERA medroxyprogesterone acetate TABLET;ORAL 011839 NDA Pharmacia & Upjohn Company LLC 0009-0065 0009-0065-01 100 TABLET in 1 BOTTLE (0009-0065-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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