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Last Updated: November 30, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 072423

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NDA 072423 describes MEGESTROL ACETATE, which is a drug marketed by Akorn, Breckenridge, Hikma Pharms, 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 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 072423
Applicant:Par Pharm
Ingredient:megestrol acetate
Formulation / Manufacturing:see details
Pharmacology for NDA: 072423
Medical Subject Heading (MeSH) Categories for 072423
Suppliers and Packaging for NDA: 072423
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEGESTROL ACETATE megestrol acetate TABLET;ORAL 072423 ANDA Major Pharmaceuticals 0904-3571 0904-3571-61 100 BLISTER PACK in 1 CARTON (0904-3571-61) > 1 TABLET in 1 BLISTER PACK
MEGESTROL ACETATE megestrol acetate TABLET;ORAL 072423 ANDA Par Pharmaceutical, Inc. 49884-290 49884-290-01 100 TABLET in 1 BOTTLE (49884-290-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Aug 8, 1988TE:ABRLD:No

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