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Generated: December 13, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078055

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NDA 078055 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-seven 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 078055
Tradename:ZOLPIDEM TARTRATE
Applicant:Sun Pharm Inds Ltd
Ingredient:zolpidem tartrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078055
Mechanism of ActionGABA A Agonists
Physiological EffectCentral Nervous System Depression
Suppliers and Packaging for NDA: 078055
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 078055 ANDA Ranbaxy Pharmaceuticals Inc. 63304-159 63304-159-03 10 TABLET, FILM COATED in 1 BOTTLE (63304-159-03)
ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 078055 ANDA Ranbaxy Pharmaceuticals Inc. 63304-159 63304-159-10 1000 TABLET, FILM COATED in 1 BOTTLE (63304-159-10)

Profile for product number 001

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

Profile for product number 002

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

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