APPLICATION
ANDA076410
TYPE
ANDA
ORIGINAL APPROVAL
2007-04-23
LATEST ACTION
2023-03-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ZOLPIDEM TARTRATEDiscontinued
ZOLPIDEM TARTRATE 5MG · TABLET · ORAL
ZOLPIDEM TARTRATEDiscontinued
ZOLPIDEM TARTRATE 10MG · TABLET · ORAL
Approval history
2023-03-08Labeling · Supplement 28 · standardAP
2023-03-08Labeling · Supplement 29 · standardAP
2019-11-15Labeling · Supplement 17 · standardAP
2019-11-15Labeling · Supplement 23 · standardAP
2019-11-15Labeling · Supplement 21 · standardAP
2019-11-15Labeling · Supplement 24 · standardAP
2019-11-15Labeling · Supplement 19 · standardAP
2015-03-19Labeling · Supplement 14 · standardAP
2013-09-04Labeling · Supplement 13 · standardAP
2010-12-08Labeling · Supplement 8AP
2008-11-06Labeling · Supplement 4AP
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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