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Details for New Drug Application (NDA): 077238

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NDA 077238 describes ZALEPLON, which is a drug marketed by Cipla Ltd, Upsher Smith, Aurobindo Pharma, Roxane, Mylan, Teva Pharms, Hikma Pharms Llc, Orchid Hlthcare, Unichem, and Upsher-smith Labs, and is included in ten NDAs. It is available from twenty-one 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-four suppliers are listed for this compound. Additional details are available on the zaleplon profile page.

Summary for NDA: 077238

Tradename:
ZALEPLON
Applicant:
Mylan
Ingredient:
zaleplon
Patents:0
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details

Pharmacology for NDA: 077238

Mechanism of ActionGABA A Agonists
Physiological EffectCentral Nervous System Depression

Suppliers and Packaging for NDA: 077238

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZALEPLON
zaleplon
CAPSULE;ORAL 077238 ANDA PD-Rx Pharmaceuticals, Inc. 43063-240 43063-240-30 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-240-30)

Summary for product number 001

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

Summary for product number 002

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


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