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Generated: May 22, 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-two 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-five 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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