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Generated: March 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078179

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NDA 078179 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-seven 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-four suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.
Summary for 078179
Applicant:Actavis Elizabeth
Ingredient:zolpidem tartrate
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details
Pharmacology for NDA: 078179
Mechanism of ActionGABA A Agonists
Physiological EffectCentral Nervous System Depression
Suppliers and Packaging for NDA: 078179
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLPIDEM TARTRATE zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 078179 ANDA Actavis Pharma, Inc. 0228-3481 N 0228-3481-11
ZOLPIDEM TARTRATE zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 078179 ANDA Actavis Pharma, Inc. 0228-3482 N 0228-3482-11

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength12.5MG
Approval Date:Jun 6, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength6.25MG
Approval Date:Oct 13, 2010TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

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