Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Deloitte
UBS
Cantor Fitzgerald
Chubb
Mallinckrodt
Citi
Farmers Insurance
Julphar

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078829

« Back to Dashboard

NDA 078829 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 thirteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the zaleplon profile page.
Summary for 078829
Tradename:ZALEPLON
Applicant:Aurobindo Pharma
Ingredient:zaleplon
Patents:0
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details
Pharmacology for NDA: 078829
Mechanism of ActionGABA A Agonists
Physiological EffectCentral Nervous System Depression
Suppliers and Packaging for NDA: 078829
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZALEPLON zaleplon CAPSULE;ORAL 078829 ANDA PD-Rx Pharmaceuticals, Inc. 43063-505 N 43063-505-30
ZALEPLON zaleplon CAPSULE;ORAL 078829 ANDA Rising Health, LLC 57237-239 N 57237-239-01

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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Queensland Health
Boehringer Ingelheim
Farmers Insurance
Teva
US Department of Justice
Dow
Mallinckrodt
UBS

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.