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Last Updated: January 26, 2022

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203960


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NDA 203960 describes MEGESTROL ACETATE, which is a drug marketed by Akorn, Breckenridge, Hikma, Pharm Assoc, Strides Pharma, Teva Pharms, Twi Pharms, Wockhardt Bio Ag, Barr, Teva, and Usl Pharma, and is included in fifteen NDAs. It is available from fifteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the megestrol acetate profile page.
Summary for 203960
Tradename:MEGESTROL ACETATE
Applicant:Akorn
Ingredient:megestrol acetate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203960
Medical Subject Heading (MeSH) Categories for 203960
Suppliers and Packaging for NDA: 203960
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEGESTROL ACETATE megestrol acetate SUSPENSION;ORAL 203960 ANDA Hi-Tech Pharmacal Co., Inc. 50383-859 50383-859-11 4 TRAY in 1 CASE (50383-859-11) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (50383-859-10)
MEGESTROL ACETATE megestrol acetate SUSPENSION;ORAL 203960 ANDA Hi-Tech Pharmacal Co., Inc. 50383-859 50383-859-12 10 TRAY in 1 CASE (50383-859-12) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (50383-859-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength40MG/ML
Approval Date:Jun 9, 2017TE:ABRLD:No

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