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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Argus Health
Medtronic
Covington
Julphar
Express Scripts
Colorcon
Queensland Health
US Army
Deloitte

Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075997

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NDA 075997 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 075997
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: 075997
Ingredient-typeProgesterone Congeners
Medical Subject Heading (MeSH) Categories for 075997
Suppliers and Packaging for NDA: 075997
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEGESTROL ACETATE megestrol acetate SUSPENSION;ORAL 075997 ANDA West-Ward Pharmaceuticals Corp. 0054-3542 N 0054-3542-58

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength40MG/ML
Approval Date:Feb 15, 2002TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Fuji
Fish and Richardson
AstraZeneca
Moodys
McKesson
Cipla
Mallinckrodt
Chubb

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