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Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040159

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NDA 040159 describes MEDROXYPROGESTERONE ACETATE, which is a drug marketed by Amphastar Pharms Inc, Sandoz Inc, Teva Pharms Usa, Barr, Duramed Pharms Barr, and Usl Pharma, and is included in eight NDAs. It is available from eighteen suppliers. Additional details are available on the MEDROXYPROGESTERONE ACETATE profile page.

The generic ingredient in MEDROXYPROGESTERONE ACETATE 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 040159
Pharmacology for NDA: 040159
Ingredient-typeProgesterone Congeners
Suppliers and Packaging for NDA: 040159
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEDROXYPROGESTERONE ACETATE medroxyprogesterone acetate TABLET;ORAL 040159 ANDA Teva Pharmaceuticals USA, Inc. 0555-0779 N 0555-0779-02
MEDROXYPROGESTERONE ACETATE medroxyprogesterone acetate TABLET;ORAL 040159 ANDA Teva Pharmaceuticals USA, Inc. 0555-0779 N 0555-0779-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Aug 9, 1996TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Aug 9, 1996TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Aug 9, 1996TE:ABRLD:No

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