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US Department of Justice
Cantor Fitzgerald
Covington
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Medtronic
Daiichi Sankyo
Cipla
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Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077322

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NDA 077322 describes ZOLPIDEM TARTRATE, which is a drug marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Anchen Pharms, Apotex Inc, Lupin Ltd, Sandoz, Sun Pharma Global, Synthon Pharms, Acme Labs, Aurobindo Pharma, Cipla Ltd, Dr Reddys Labs Ltd, Hikma, Invagen Pharms, Mylan, Mylan Pharms Inc, Sandoz Inc, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Torrent Pharms, Vintage, Vivimed Global, Watson Labs, Wockhardt, Yung Shin Pharm, Dr Reddys Labs Inc, Novel Labs Inc, Par Form, and Par Pharm Inc, and is included in thirty-four NDAs. It is available from forty-six suppliers. Additional details are available on the ZOLPIDEM TARTRATE profile page.

The generic ingredient in ZOLPIDEM TARTRATE is zolpidem tartrate. There are thirty-two drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.
Summary for 077322
Tradename:ZOLPIDEM TARTRATE
Applicant:Sandoz Inc
Ingredient:zolpidem tartrate
Patents:0
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details
Pharmacology for NDA: 077322
Ingredient-typePyridines
Mechanism of ActionGABA A Agonists
Physiological EffectCentral Nervous System Depression
Suppliers and Packaging for NDA: 077322
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 077322 NDA KAISER FOUNDATION HOSPITALS 0179-1980 N 0179-1980-15
ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 077322 NDA KAISER FOUNDATION HOSPITALS 0179-1980 N 0179-1980-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Apr 23, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Apr 23, 2007TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Medtronic
Harvard Business School
Accenture
Federal Trade Commission
UBS
US Army
Queensland Health
McKinsey

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