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Cipla
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Dow
Fuji
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US Army
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Farmers Insurance

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076553

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NDA 076553 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 076553
Pharmacology for NDA: 076553
Ingredient-typeProgesterone Congeners
Suppliers and Packaging for NDA: 076553
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEDROXYPROGESTERONE ACETATE medroxyprogesterone acetate INJECTABLE;INJECTION 076553 ANDA Teva Parenteral Medicines, Inc. 0703-6801 N 0703-6801-01
MEDROXYPROGESTERONE ACETATE medroxyprogesterone acetate INJECTABLE;INJECTION 076553 ANDA Teva Parenteral Medicines, Inc. 0703-6801 N 0703-6801-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength150MG/ML
Approval Date:Jul 28, 2004TE:ABRLD:No

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McKesson
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US Department of Justice
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