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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Dow
US Army
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Harvard Business School
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Covington
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Generated: December 13, 2017

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

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Sedatives/Hypnotics
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 Northstar Rx LLC 16714-551 16714-551-02 100 CAPSULE in 1 BOTTLE (16714-551-02)
ZALEPLON zaleplon CAPSULE;ORAL 090374 ANDA Northstar Rx LLC 16714-561 16714-561-02 100 CAPSULE in 1 BOTTLE (16714-561-02)

Summary for product number 001

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

Summary for product number 002

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


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Serving leading biopharmaceutical companies globally:

Medtronic
Fish and Richardson
Accenture
Queensland Health
Farmers Insurance
Express Scripts
Cipla
McKinsey
Chinese Patent Office
McKesson

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