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Last Updated: November 2, 2024

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

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength400MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Expired US Patents for NDA 012541

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

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