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Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078989

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NDA 078989 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 078989
Tradename:ZALEPLON
Applicant:Unichem
Ingredient:zaleplon
Patents:0
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details
Pharmacology for NDA: 078989
Mechanism of ActionGABA A Agonists
Physiological EffectCentral Nervous System Depression
Suppliers and Packaging for NDA: 078989
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZALEPLON zaleplon CAPSULE;ORAL 078989 ANDA Unichem Pharmaceuticals (USA), Inc. 29300-131 N 29300-131-13
ZALEPLON zaleplon CAPSULE;ORAL 078989 ANDA Unichem Pharmaceuticals (USA), Inc. 29300-131 N 29300-131-01

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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