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Serving leading biopharmaceutical companies globally:

Baxter
Federal Trade Commission
McKesson
Healthtrust
Covington
Cipla
Express Scripts
Julphar
Medtronic
Chubb

Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074458

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NDA 074458 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 074458
Tradename:MEGESTROL ACETATE
Applicant:West-ward Pharms Int
Ingredient:megestrol acetate
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 074458
Ingredient-typeProgesterone Congeners
Medical Subject Heading (MeSH) Categories for 074458
Suppliers and Packaging for NDA: 074458
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEGESTROL ACETATE megestrol acetate TABLET;ORAL 074458 ANDA West-Ward Pharmaceuticals Corp. 0054-4603 N 0054-4603-25
MEGESTROL ACETATE megestrol acetate TABLET;ORAL 074458 ANDA West-Ward Pharmaceuticals Corp. 0054-4604 N 0054-4604-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Sep 29, 1995TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Sep 29, 1995TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Chinese Patent Office
Cipla
US Department of Justice
Johnson and Johnson
Medtronic
Colorcon
QuintilesIMS
Daiichi Sankyo

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