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Generated: September 20, 2018

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Details for New Drug Application (NDA): 077903

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NDA 077903 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 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-three suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.
Summary for 077903
Tradename:ZOLPIDEM TARTRATE
Applicant:Torrent Pharms
Ingredient:zolpidem tartrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077903
Ingredient-typePyridines
Mechanism of ActionGABA A Agonists
Physiological EffectCentral Nervous System Depression
Suppliers and Packaging for NDA: 077903
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 077903 ANDA Major Pharmaceuticals 0904-6082 0904-6082-61 100 BLISTER PACK in 1 CARTON (0904-6082-61) > 1 TABLET in 1 BLISTER PACK
ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 077903 ANDA Major Pharmaceuticals 0904-6083 0904-6083-61 100 BLISTER PACK in 1 CARTON (0904-6083-61) > 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Aug 17, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Aug 17, 2007TE:ABRLD:No

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