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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Deloitte
Boehringer Ingelheim
Fish and Richardson
Chubb
Argus Health
Federal Trade Commission
US Army
Queensland Health

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077237

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NDA 077237 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 077237
Tradename:ZALEPLON
Applicant:West-ward Pharms Int
Ingredient:zaleplon
Patents:0
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details
Pharmacology for NDA: 077237
Mechanism of ActionGABA A Agonists
Physiological EffectCentral Nervous System Depression
Suppliers and Packaging for NDA: 077237
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZALEPLON zaleplon CAPSULE;ORAL 077237 ANDA West-Ward Pharmaceuticals Corp. 0054-0084 N 0054-0084-25
ZALEPLON zaleplon CAPSULE;ORAL 077237 ANDA West-Ward Pharmaceuticals Corp. 0054-0085 N 0054-0085-25

Profile for product number 001

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

Profile for product number 002

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

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
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Accenture
Julphar
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Cerilliant
Johnson and Johnson
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