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Last Updated: August 17, 2022

Details for New Drug Application (NDA): 078147


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NDA 078147 describes ZALEPLON, which is a drug marketed by Aurobindo Pharma, Chartwell Molecular, Hikma, Hikma Pharms, Mylan, Orbion Pharms, Teva Pharms, Unichem, and Upsher Smith Labs, and is included in ten NDAs. It is available from ten 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. Ten suppliers are listed for this compound. Additional details are available on the zaleplon profile page.
Summary for 078147
Tradename:ZALEPLON
Applicant:Hikma Pharms
Ingredient:zaleplon
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength5MG
Approval Date:Nov 25, 2008TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength10MG
Approval Date:Nov 25, 2008TE:RLD:No

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