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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 077237


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NDA 077237 describes ZALEPLON, which is a drug marketed by Aurobindo Pharma, Chartwell Molecular, Hikma, Hikma Pharms, Natco Pharma, 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 077237
Tradename:ZALEPLON
Applicant:Hikma
Ingredient:zaleplon
Patents:0
Pharmacology for NDA: 077237
Mechanism of ActionGABA A Agonists
Physiological EffectCentral Nervous System Depression
Suppliers and Packaging for NDA: 077237
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZALEPLON zaleplon CAPSULE;ORAL 077237 ANDA Hikma Pharmaceuticals USA Inc. 0054-0084 0054-0084-25 100 CAPSULE in 1 BOTTLE (0054-0084-25)
ZALEPLON zaleplon CAPSULE;ORAL 077237 ANDA Hikma Pharmaceuticals USA Inc. 0054-0085 0054-0085-25 100 CAPSULE in 1 BOTTLE (0054-0085-25)

Profile for product number 001

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

Profile for product number 002

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

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