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QuintilesIMS

Generated: December 11, 2017

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 Apotex Inc, Hi-tech Pharmacal, Par Pharm, Teva Pharms, Twi Pharms Inc, West-ward Pharms Int, Wockhardt, Barr, Teva, and Usl Pharma, and is included in fourteen NDAs. It is available from twenty-two 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 072423

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 072423

Ingredient-typeProgesterone Congeners

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 NCS HealthCare of KY, Inc dba Vangard Labs 0615-3570 0615-3570-39 30 TABLET in 1 BLISTER PACK (0615-3570-39)
MEGESTROL ACETATE 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)

Summary for product number 001

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


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Julphar
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