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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 six suppliers. Additional details are available on the PROVERA profile page.

The generic ingredient in PROVERA is medroxyprogesterone acetate. There are nineteen 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 NDA: 011839

Tradename:
PROVERA
Applicant:
Pharmacia And Upjohn
Ingredient:
medroxyprogesterone acetate
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
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 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 0009-0050 0009-0050-11 500 TABLET in 1 BOTTLE (0009-0050-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Summary 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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