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Generated: May 25, 2017

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Details for New Drug Application (NDA): 072423

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NDA 072423 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, and Teva Pharms, and is included in thirteen NDAs. It is available from twenty-three 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-six suppliers are listed for this compound. Additional details are available on the megestrol acetate profile page.

Summary for NDA: 072423

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 072423

Ingredient-typeProgesterone Congeners

Suppliers and Packaging for NDA: 072423

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
megestrol acetate
TABLET;ORAL 072423 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-3570 0615-3570-31 31 TABLET in 1 BLISTER PACK (0615-3570-31)
megestrol acetate
TABLET;ORAL 072423 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-3570 0615-3570-39 30 TABLET in 1 BLISTER PACK (0615-3570-39)

Summary for product number 001

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

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