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Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077505

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NDA 077505 describes ZALEPLON, which is a drug marketed by Cipla Ltd, Upsher Smith, Aurobindo Pharma, West-ward Pharms Int, Mylan, Teva Pharms, Hikma Pharms Llc, Orchid Hlthcare, Unichem, and Upsher-smith Labs, and is included in ten NDAs. It is available from twenty 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-three suppliers are listed for this compound. Additional details are available on the zaleplon profile page.

Summary for NDA: 077505

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Jun 20, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Jun 20, 2008TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
US Department of Justice
Deloitte
Chinese Patent Office
Merck
McKinsey
Medtronic
Citi
Mallinckrodt
Harvard Business School

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