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Generated: November 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090374

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NDA 090374 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 090374
Applicant:Orchid Hlthcare
Formulation / Manufacturing:see details
Pharmacology for NDA: 090374
Mechanism of ActionGABA A Agonists
Physiological EffectCentral Nervous System Depression
Suppliers and Packaging for NDA: 090374
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZALEPLON zaleplon CAPSULE;ORAL 090374 ANDA OrchidPharma Inc 42043-210 42043-210-01 100 CAPSULE in 1 BOTTLE (42043-210-01)
ZALEPLON zaleplon CAPSULE;ORAL 090374 ANDA OrchidPharma Inc 42043-211 42043-211-01 100 CAPSULE in 1 BOTTLE (42043-211-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Sep 17, 2009TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Sep 17, 2009TE:ABRLD:No

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