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FDA ANDA · ANDA078616

ZOLPIDEM TARTRATE

Sponsor: STRIDES PHARMA INTL

APPLICATION
ANDA078616
TYPE
ANDA
ORIGINAL APPROVAL
2008-11-21
LATEST ACTION
2022-09-02
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

2022-09-02Labeling · Supplement 17 · standardAP
2020-08-25Labeling · Supplement 13 · standardAP
2020-08-25Labeling · Supplement 16 · standardAP
2020-08-25Labeling · Supplement 12 · standardAP
2015-04-02Labeling · Supplement 9 · standardAP
2013-09-04Labeling · Supplement 7 · standardAP
2010-08-16Labeling · Supplement 2AP
2008-11-21Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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