APPLICATION
ANDA077884
TYPE
ANDA
ORIGINAL APPROVAL
2007-04-23
LATEST ACTION
2022-09-28
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
2022-09-28Labeling · Supplement 22 · standardAP
2019-10-25Labeling · Supplement 18 · standardAP
2019-10-25Labeling · Supplement 16 · standardAP
2019-10-25Labeling · Supplement 19 · standardAP
2019-10-25Labeling · Supplement 17 · standardAP
2019-10-25Labeling · Supplement 15 · standardAP
2014-12-13Labeling · Supplement 14 · standardAP
2014-12-13Labeling · Supplement 13 · standardAP
2011-02-04Labeling · Supplement 11AP
2009-01-21Labeling · Supplement 9AP
2008-05-29Labeling · Supplement 5AP
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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