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Generated: November 20, 2018

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Details for New Drug Application (NDA): 012541

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NDA 012541 describes DEPO-PROVERA, which is a drug marketed by Pharmacia And Upjohn and is included in two NDAs. It is available from five 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-five suppliers are listed for this compound. Additional details are available on the medroxyprogesterone acetate profile page.
Summary for 012541
Tradename:DEPO-PROVERA
Applicant:Pharmacia And Upjohn
Ingredient:medroxyprogesterone acetate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 012541
Ingredient-typeProgesterone Congeners
Suppliers and Packaging for NDA: 012541
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEPO-PROVERA medroxyprogesterone acetate INJECTABLE;INJECTION 012541 NDA Pharmacia and Upjohn Company LLC 0009-0626 0009-0626-01 1 VIAL in 1 CARTON (0009-0626-01) > 2.5 mL in 1 VIAL

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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage: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
Pharmacia And Upjohn DEPO-PROVERA medroxyprogesterone acetate INJECTABLE;INJECTION 012541-002 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Pharmacia And Upjohn 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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