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Serving leading biopharmaceutical companies globally:

Accenture
Colorcon
AstraZeneca
Express Scripts
Baxter
McKesson
Boehringer Ingelheim
Federal Trade Commission
Farmers Insurance
US Department of Justice

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078970

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NDA 078970 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-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 078970
Tradename:ZOLPIDEM TARTRATE
Applicant:Lupin Ltd
Ingredient:zolpidem tartrate
Patents:0
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details
Pharmacology for NDA: 078970
Ingredient-typePyridines
Mechanism of ActionGABA A Agonists
Physiological EffectCentral Nervous System Depression
Suppliers and Packaging for NDA: 078970
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLPIDEM TARTRATE zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 078970 ANDA Lupin Pharmaceuticals, Inc. 68180-779 68180-779-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-779-01)
ZOLPIDEM TARTRATE zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 078970 ANDA Lupin Pharmaceuticals, Inc. 68180-779 68180-779-13 5 BLISTER PACK in 1 CARTON (68180-779-13) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68180-779-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength6.25MG
Approval Date:Sep 11, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength12.5MG
Approval Date:Sep 11, 2013TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Express Scripts
Colorcon
Julphar
McKesson
US Army
Merck
Dow
Teva
Johnson and Johnson

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