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FDA NDA · NDA021774

AMBIEN CR

zolpidem tartrate

Sponsor: COSETTE

APPLICATION
NDA021774
TYPE
NDA
ORIGINAL APPROVAL
2005-09-02
LATEST ACTION
2022-02-23
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

AMBIEN CR · ReferencePrescription
ZOLPIDEM TARTRATE 6.25MG · TABLET, EXTENDED RELEASE · ORAL
AMBIEN CR · ReferencePrescription
ZOLPIDEM TARTRATE 12.5MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2022-02-23Labeling · Supplement 25 · standard — Letter ↗AP
2022-02-23Labeling · Supplement 21 · standard — Letter ↗AP
2022-02-23Labeling · Supplement 28 · standard — Letter ↗AP
2019-08-18Labeling · Supplement 27 · standard — Letter ↗AP
2019-02-06Labeling · Supplement 26 · 901 required — Label ↗AP
2018-09-14Labeling · Supplement 23 · standard — Letter ↗AP
2017-03-03Labeling · Supplement 19 · standard — Label ↗AP
2016-12-02Labeling · Supplement 18 · standard — Label ↗AP
2016-08-11Labeling · Supplement 17 · standard — Letter ↗AP
2014-10-07Labeling · Supplement 16 · standard — Label ↗AP
2013-04-19Labeling · Supplement 15 · standard — Letter ↗AP
2013-04-19Labeling · Supplement 13 · standard — Label ↗AP
2010-04-14Labeling · Supplement 10 · unknown — Letter ↗AP
2007-12-20Efficacy · Supplement 5 · standard — Label ↗AP
2007-12-20Efficacy · Supplement 3 · unknown — Label ↗AP
2007-12-20Efficacy · Supplement 8 · standard — Label ↗AP
2007-12-20Efficacy · Supplement 4 · standard — Letter ↗AP
2007-12-20Labeling · Supplement 7 · standard — Label ↗AP
2005-09-02Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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