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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Argus Health
US Department of Justice
Fuji
Colorcon
Boehringer Ingelheim
Novartis
Covington
Mallinckrodt
UBS

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090107

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NDA 090107 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, Allied Pharma Inc, 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 fifty-eight 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. Sixty-five suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.
Summary for 090107
Tradename:ZOLPIDEM TARTRATE
Applicant:Sandoz
Ingredient:zolpidem tartrate
Patents:0
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details
Pharmacology for NDA: 090107
Ingredient-typePyridines
Mechanism of ActionGABA A Agonists
Physiological EffectCentral Nervous System Depression
Suppliers and Packaging for NDA: 090107
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLPIDEM TARTRATE zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 090107 ANDA Sandoz Inc 0781-5315 0781-5315-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5315-05)
ZOLPIDEM TARTRATE zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 090107 ANDA Sandoz Inc 0781-5315 0781-5315-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5315-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength6.25MG
Approval Date:Jul 1, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength12.5MG
Approval Date:Jul 1, 2011TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

McKinsey
UBS
Baxter
Deloitte
Farmers Insurance
Cantor Fitzgerald
Medtronic
Chubb
Federal Trade Commission

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