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Generated: November 14, 2018

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Details for New Drug Application (NDA): 011839

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NDA 011839 describes PROVERA, which is a drug marketed by Pharmacia And Upjohn and is included in one NDA. It is available from five 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-five suppliers are listed for this compound. Additional details are available on the medroxyprogesterone acetate profile page.
Summary for 011839
Tradename:PROVERA
Applicant:Pharmacia And Upjohn
Ingredient:medroxyprogesterone acetate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 011839
Ingredient-typeProgesterone Congeners
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 and Upjohn Company LLC 0009-0050 0009-0050-02 1 BOTTLE in 1 CARTON (0009-0050-02) > 100 TABLET in 1 BOTTLE
PROVERA medroxyprogesterone acetate TABLET;ORAL 011839 NDA Pharmacia and Upjohn Company LLC 0009-0050 0009-0050-11 500 TABLET in 1 BOTTLE (0009-0050-11)

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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