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Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077238

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NDA 077238 describes ZALEPLON, which is a drug marketed by Aurobindo Pharma, Cipla Ltd, Hikma Pharms, Mylan, Orchid Hlthcare, Teva Pharms, Unichem, Upsher-smith Labs, and West-ward Pharms Int, and is included in ten NDAs. It is available from nineteen suppliers. Additional details are available on the ZALEPLON profile page.

The generic ingredient in ZALEPLON is zaleplon. There are twelve drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the zaleplon profile page.
Summary for 077238
Tradename:ZALEPLON
Applicant:Mylan
Ingredient:zaleplon
Patents:0
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength5MG
Approval Date:Jun 6, 2008TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength10MG
Approval Date:Jun 6, 2008TE:RLD:No

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