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Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078616

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NDA 078616 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-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 078616
Tradename:ZOLPIDEM TARTRATE
Applicant:Vintage
Ingredient:zolpidem tartrate
Patents:0
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details
Pharmacology for NDA: 078616
Ingredient-typePyridines
Mechanism of ActionGABA A Agonists
Physiological EffectCentral Nervous System Depression
Suppliers and Packaging for NDA: 078616
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 078616 ANDA Blenheim Pharmacal, Inc. 10544-539 E 10544-539-30
ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 078616 ANDA Blenheim Pharmacal, Inc. 10544-540 E 10544-540-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Nov 21, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Nov 21, 2008TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
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