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Serving leading biopharmaceutical companies globally:

McKesson
Fish and Richardson
Cantor Fitzgerald
Novartis
Chubb
Moodys
QuintilesIMS
Express Scripts
AstraZeneca
Deloitte

Generated: December 11, 2017

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, Hi-tech Pharmacal, Par Pharm, Teva Pharms, Twi Pharms Inc, West-ward Pharms Int, Wockhardt, Barr, Teva, and Usl Pharma, and is included in fourteen 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-six suppliers are listed for this compound. Additional details are available on the megestrol acetate profile page.

Summary for 074458

Tradename:1
Applicant:1
Ingredient:1
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 0054-4603-25 100 TABLET in 1 BOTTLE, PLASTIC (0054-4603-25)
MEGESTROL ACETATE megestrol acetate TABLET;ORAL 074458 ANDA West-Ward Pharmaceuticals Corp. 0054-4604 0054-4604-25 100 TABLET in 1 BOTTLE, PLASTIC (0054-4604-25)

Summary for product number 001

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

Summary for product number 002

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


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Serving leading biopharmaceutical companies globally:

Accenture
Daiichi Sankyo
US Army
US Department of Justice
Queensland Health
Deloitte
Express Scripts
Johnson and Johnson
Dow
Boehringer Ingelheim

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