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FDA ANDA · ANDA078184

ZOLPIDEM TARTRATE

Sponsor: INVAGEN PHARMS

APPLICATION
ANDA078184
TYPE
ANDA
ORIGINAL APPROVAL
2007-09-07
LATEST ACTION
2022-10-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ZOLPIDEM TARTRATEDiscontinued
ZOLPIDEM TARTRATE 10MG · TABLET · ORAL
ZOLPIDEM TARTRATEDiscontinued
ZOLPIDEM TARTRATE 5MG · TABLET · ORAL

Approval history

2022-10-26Labeling · Supplement 6 · standardAP
2020-06-22Labeling · Supplement 5 · standardAP
2008-09-03Labeling · Supplement 2AP
2008-05-29Labeling · Supplement 1AP
2007-09-07Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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