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Serving 500+ biopharmaceutical companies globally:

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Generated: June 24, 2017

DrugPatentWatch Database Preview

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, 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: 077238

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 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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Serving 500+ biopharmaceutical companies globally:

AstraZeneca
Cerilliant
McKinsey
Johnson and Johnson
Colorcon
Merck
Farmers Insurance
Harvard Business School
Boehringer Ingelheim
Express Scripts

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