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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078148

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NDA 078148 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-one drug master file entries for this compound. Sixty-six suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.

Summary for 078148

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details

Pharmacology for NDA: 078148

Ingredient-typePyridines
Mechanism of ActionGABA A Agonists
Physiological EffectCentral Nervous System Depression

Suppliers and Packaging for NDA: 078148

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLPIDEM TARTRATE zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 078148 ANDA Par Pharmaceutical, Inc. 10370-116 10370-116-10 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-116-10)
ZOLPIDEM TARTRATE zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 078148 ANDA Par Pharmaceutical, Inc. 10370-117 10370-117-10 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-117-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength12.5MG
Approval Date:Dec 3, 2010TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength6.25MG
Approval Date:Apr 14, 2011TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Express Scripts
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US Army
Healthtrust
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Dow
Merck

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