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Details for New Drug Application (NDA): 076410

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NDA 076410 describes ZOLPIDEM TARTRATE, which is a drug marketed by Torrent Pharms, Sandoz, Par Form, Teva, Aurobindo Pharma, Roxane, 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, Watson Labs, Mylan, Actavis Elizabeth, Invagen Pharms, Dr Reddys Labs Ltd, Cipla Ltd, Sun Pharm Inds, Carlsbad, and Novel Labs Inc, and is included in thirty-one NDAs. It is available from fifty-nine suppliers. Additional details are available on the ZOLPIDEM TARTRATE profile page.

The generic ingredient in ZOLPIDEM TARTRATE is zolpidem tartrate. There are thirty 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 NDA: 076410

zolpidem tartrate
Therapeutic Class:Sedatives/Hypnotics

Pharmacology for NDA: 076410

Mechanism of ActionGABA A Agonists
Physiological EffectCentral Nervous System Depression

Suppliers and Packaging for NDA: 076410

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
zolpidem tartrate
TABLET;ORAL 076410 ANDA Teva Pharmaceuticals USA Inc 0093-0073 0093-0073-01 100 TABLET, FILM COATED in 1 BOTTLE (0093-0073-01)
zolpidem tartrate
TABLET;ORAL 076410 ANDA Teva Pharmaceuticals USA Inc 0093-0074 0093-0074-01 100 TABLET, FILM COATED in 1 BOTTLE (0093-0074-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Apr 23, 2007TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Apr 23, 2007TE:ABRLD:No

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