← FDA DRUG APPROVALS

FDA NDA · NDA019908

AMBIEN

zolpidem tartrate

Sponsor: COSETTE

APPLICATION
NDA019908
TYPE
NDA
ORIGINAL APPROVAL
1992-12-16
LATEST ACTION
2022-02-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

AMBIEN · ReferencePrescription
ZOLPIDEM TARTRATE 10MG · TABLET · ORAL
AMBIEN · ReferencePrescription
ZOLPIDEM TARTRATE 5MG · TABLET · ORAL

Approval history

2022-02-23Labeling · Supplement 40 · standard — Letter ↗AP
2022-02-23Labeling · Supplement 47 · standard — Letter ↗AP
2022-02-23Labeling · Supplement 44 · standard — Letter ↗AP
2019-08-18Labeling · Supplement 46 · standard — Letter ↗AP
2019-02-06Labeling · Supplement 45 · 901 required — Label ↗AP
2018-09-14Labeling · Supplement 42 · standard — Letter ↗AP
2017-03-03Labeling · Supplement 38 · standard — Label ↗AP
2016-12-02Labeling · Supplement 37 · standard — Label ↗AP
2016-08-11Labeling · Supplement 36 · standard — Label ↗AP
2014-10-07Labeling · Supplement 35 · standard — Letter ↗AP
2013-06-05Manufacturing (CMC) · Supplement 33 · standardAP
2013-04-19Labeling · Supplement 34 · 901 required — Label ↗AP
2013-04-19Labeling · Supplement 32 · standard — Label ↗AP
2010-04-14Labeling · Supplement 29 · unknown — Letter ↗AP
2008-05-07Labeling · Supplement 27 · standard — Review ↗AP
2007-10-04Labeling · Supplement 24 · standard — Letter ↗AP
2007-10-04Labeling · Supplement 20 · standard — Letter ↗AP
2007-10-04Labeling · Supplement 25 · standard — Review ↗AP
2007-03-28Efficacy · Supplement 22 · priority — Pediatric Medical Review ↗AP
2002-09-25Manufacturing (CMC) · Supplement 15 · standardAP
2002-05-21Manufacturing (CMC) · Supplement 14 · standardAP
2002-01-15Manufacturing (CMC) · Supplement 13 · standardAP
2001-11-15Manufacturing (CMC) · Supplement 12 · standardAP
2001-05-04Manufacturing (CMC) · Supplement 11 · standardAP
2001-04-13Manufacturing (CMC) · Supplement 10 · standardAP
1999-12-01Labeling · Supplement 9 · standardAP
1996-04-18Manufacturing (CMC) · Supplement 5 · standardAP
1995-10-04Manufacturing (CMC) · Supplement 4 · standardAP
1995-07-14Labeling · Supplement 2 · standard — Review ↗AP
1995-07-14Labeling · Supplement 1 · standardAP
1995-01-09Manufacturing (CMC) · Supplement 3 · standardAP
1992-12-16Type 1 - New Molecular Entity · Original · standard — Review ↗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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