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UBS
US Department of Justice
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US Army
Federal Trade Commission
Dow
Mallinckrodt
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Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074621

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NDA 074621 describes MEGESTROL ACETATE, which is a drug marketed by Apotex Inc, Breckenridge Pharm, Hi-tech Pharmacal, Par Pharm, Teva Pharms, Twi Pharms Inc, West-ward Pharms Int, Wockhardt Bio Ag, Barr, Teva, and Usl Pharma, and is included in fifteen NDAs. It is available from twenty-two suppliers. Additional details are available on the MEGESTROL ACETATE profile page.

The generic ingredient in MEGESTROL ACETATE is megestrol acetate. There are eighteen drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the megestrol acetate profile page.
Summary for 074621
Tradename:MEGESTROL ACETATE
Applicant:Barr
Ingredient:megestrol acetate
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 074621
Ingredient-typeProgesterone Congeners
Medical Subject Heading (MeSH) Categories for 074621
Suppliers and Packaging for NDA: 074621
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEGESTROL ACETATE megestrol acetate TABLET;ORAL 074621 ANDA Teva Pharmaceuticals USA, Inc. 0555-0606 N 0555-0606-02
MEGESTROL ACETATE megestrol acetate TABLET;ORAL 074621 ANDA Teva Pharmaceuticals USA, Inc. 0555-0607 N 0555-0607-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Nov 30, 1995TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Aug 16, 1996TE:ABRLD:No

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Daiichi Sankyo
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