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Last Updated: March 31, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076721


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NDA 076721 describes MEGESTROL ACETATE, which is a drug marketed by Breckenridge, Hi Tech, Hikma, Par Pharm, Pharm Assoc, Teva Pharms, Twi Pharms, Wockhardt Bio Ag, Barr, Teva, and Usl Pharma, and is included in fifteen NDAs. It is available from sixteen 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. Seventeen suppliers are listed for this compound. Additional details are available on the megestrol acetate profile page.
Summary for 076721
Tradename:MEGESTROL ACETATE
Applicant:Wockhardt Bio Ag
Ingredient:megestrol acetate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076721
Medical Subject Heading (MeSH) Categories for 076721
Suppliers and Packaging for NDA: 076721
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEGESTROL ACETATE megestrol acetate SUSPENSION;ORAL 076721 ANDA Pharmaceutical Associates, Inc. 0121-4776 0121-4776-00 10 TRAY in 1 CASE (0121-4776-00) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (0121-4776-10)
MEGESTROL ACETATE megestrol acetate SUSPENSION;ORAL 076721 ANDA Pharmaceutical Associates, Inc. 0121-4776 0121-4776-35 10 TRAY in 1 CASE (0121-4776-35) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength40MG/ML
Approval Date:Nov 1, 2004TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

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Dow
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Mallinckrodt

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