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Generated: November 22, 2017

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 Torrent Pharms, Dr Reddys Labs Inc, Sandoz, Par Form, Teva, Aurobindo Pharma, Allied Pharma Inc, Mylan Pharms Inc, Vintage, Sandoz Inc, Wockhardt, Hikma, Par Pharm Inc, Synthon Pharms, Anchen Pharms, Actavis Labs Fl Inc, Sun Pharm Inds Ltd, Sun Pharm Inds Inc, Vivimed Global, 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-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 078616

Tradename:
1
Applicant:
1
Ingredient:
1
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 10544-539-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10544-539-30)
ZOLPIDEM TARTRATE
zolpidem tartrate
TABLET;ORAL 078616 ANDA Blenheim Pharmacal, Inc. 10544-540 10544-540-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10544-540-30)

Summary for product number 001

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

Summary for product number 002

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


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