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Generated: January 16, 2019

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Details for New Drug Application (NDA): 077214

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NDA 077214 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, Strides Vivimed, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Torrent Pharms, Vintage, 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-six suppliers. Additional details are available on the ZOLPIDEM TARTRATE profile page.

The generic ingredient in ZOLPIDEM TARTRATE is zolpidem tartrate. There are thirty-three drug master file entries for this compound. Sixty-two suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.
Summary for 077214
Tradename:ZOLPIDEM TARTRATE
Applicant:Acme Labs
Ingredient:zolpidem tartrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077214
Mechanism of ActionGABA A Agonists
Physiological EffectCentral Nervous System Depression

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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