← FDA DRUG APPROVALS

FDA NDA · NDA021997

EDLUAR

zolpidem tartrate

Sponsor: VIATRIS

APPLICATION
NDA021997
TYPE
NDA
ORIGINAL APPROVAL
2009-03-13
LATEST ACTION
2019-08-18
ROUTE
ORAL, SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

EDLUAR · ReferencePrescription
ZOLPIDEM TARTRATE 5MG · TABLET · SUBLINGUAL
EDLUAR · ReferencePrescription
ZOLPIDEM TARTRATE 10MG · TABLET · SUBLINGUAL

Approval history

2019-08-18Labeling · Supplement 11 · 901 required — Letter ↗AP
2019-02-06Labeling · Supplement 10 · 901 required — Label ↗AP
2018-10-24Labeling · Supplement 8 · standard — Label ↗AP
2014-10-29Labeling · Supplement 6 · standard — Label ↗AP
2013-04-19Labeling · Supplement 5 · 901 required — Label ↗AP
2011-08-10REMS · Supplement 3 — Letter ↗AP
2010-12-17REMS · Supplement 2 — Letter ↗AP
2009-03-13Type 3 - New Dosage Form · Original · standard — Summary 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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