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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
AstraZeneca
Medtronic
Moodys
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Covington
McKinsey
US Department of Justice
McKesson
Queensland Health

Generated: August 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203139

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NDA 203139 describes MEGESTROL ACETATE, which is a drug marketed by Apotex Inc, Wockhardt, Barr, Par Pharm, Twi Pharms Inc, Teva, Usl Pharma, West-ward Pharms Int, Hi-tech Pharmacal, and Teva Pharms, and is included in fourteen NDAs. It is available from twenty-four 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-eight suppliers are listed for this compound. Additional details are available on the megestrol acetate profile page.

Summary for NDA: 203139

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: 203139

Ingredient-typeProgesterone Congeners

Suppliers and Packaging for NDA: 203139

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEGESTROL ACETATE
megestrol acetate
SUSPENSION;ORAL 203139 ANDA TWi Pharmaceuticals, Inc. 24979-041 24979-041-13 150 mL in 1 BOTTLE (24979-041-13)
MEGESTROL ACETATE
megestrol acetate
SUSPENSION;ORAL 203139 ANDA AvKARE, Inc. 42291-588 42291-588-15 150 mL in 1 BOTTLE (42291-588-15)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength125MG/ML
Approval Date:Aug 27, 2014TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Fish and Richardson
Healthtrust
Federal Trade Commission
Covington
Moodys
Novartis
Julphar
Express Scripts
Baxter

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