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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Harvard Business School
Medtronic
Healthtrust
McKinsey
US Army
Argus Health
Chinese Patent Office
Chubb
Mallinckrodt

Generated: July 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090153

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NDA 090153 describes ZOLPIDEM TARTRATE, which is a drug marketed by Torrent Pharms, Dr Reddys Labs Inc, Sandoz, Par Form, Teva, Aurobindo Pharma, Allied Pharma Inc, Mylan Pharms Inc, Vintage, Sandoz Inc, Wockhardt, Hikma, Synthon Pharms, Anchen Pharms, Actavis Labs Fl Inc, Sun Pharm Inds Ltd, Sun Pharm Inds Inc, Vivimed Labs, Apotex Inc, Lupin Ltd, Sun Pharma Global, Watson Labs, Mylan, Actavis Elizabeth, Invagen Pharms, Dr Reddys Labs Ltd, Cipla Ltd, Sun Pharm Inds, Yung Shin Pharm, and Novel Labs Inc, and is included in thirty-three 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-five suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.

Summary for NDA: 090153

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

Pharmacology for NDA: 090153

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

Suppliers and Packaging for NDA: 090153

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLPIDEM TARTRATE
zolpidem tartrate
TABLET, EXTENDED RELEASE;ORAL 090153 ANDA Watson Laboratories, Inc. 0591-2281 0591-2281-10 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-2281-10)
ZOLPIDEM TARTRATE
zolpidem tartrate
TABLET, EXTENDED RELEASE;ORAL 090153 ANDA Watson Laboratories, Inc. 0591-2281 0591-2281-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-2281-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength6.25MG
Approval Date:Mar 25, 2013TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength12.5MG
Approval Date:Mar 25, 2013TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Chubb
McKesson
AstraZeneca
Fish and Richardson
Moodys
Daiichi Sankyo
Cantor Fitzgerald
Harvard Business School
Teva
Baxter

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