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Last Updated: December 12, 2019

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 Breckenridge, Hi Tech, Par Pharm, Pharm Assoc, Teva Pharms, Twi Pharms, West-ward Pharms Int, Wockhardt Bio Ag, Barr, Teva, and Usl Pharma, and is included in fifteen NDAs. It is available from eighteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the megestrol acetate profile page.
Summary for 203139
Tradename:MEGESTROL ACETATE
Applicant:Twi Pharms
Ingredient:megestrol acetate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203139
Medical Subject Heading (MeSH) Categories for 203139
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)

Profile for product number 001

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

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