Details for New Drug Application (NDA): 011839
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The generic ingredient in PROVERA is medroxyprogesterone acetate. There are twenty drug master file entries for this compound. Twenty-two 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 |
Formulation / Manufacturing: | see details |
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: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes |
Profile for product number 004
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes |
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