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Details for New Drug Application (NDA): 077322

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NDA 077322 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-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: 077322

Tradename:
ZOLPIDEM TARTRATE
Applicant:
Sandoz Inc
Ingredient:
zolpidem tartrate
Patents:0
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details

Pharmacology for NDA: 077322

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

Suppliers and Packaging for NDA: 077322

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLPIDEM TARTRATE
zolpidem tartrate
TABLET;ORAL 077322 NDA KAISER FOUNDATION HOSPITALS 0179-1980 0179-1980-15 15 TABLET, COATED in 1 BOTTLE (0179-1980-15)
ZOLPIDEM TARTRATE
zolpidem tartrate
TABLET;ORAL 077322 NDA KAISER FOUNDATION HOSPITALS 0179-1980 0179-1980-30 30 TABLET, COATED in 1 BOTTLE (0179-1980-30)

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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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