← FDA DRUG APPROVALS

FDA NDA · NDA021476

LUNESTA

eszopiclone

Sponsor: WAYLIS THERAP

APPLICATION
NDA021476
TYPE
NDA
ORIGINAL APPROVAL
2004-12-15
LATEST ACTION
2019-08-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LUNESTA · ReferencePrescription
ESZOPICLONE 2MG · TABLET · ORAL
LUNESTA · ReferencePrescription
ESZOPICLONE 3MG · TABLET · ORAL
LUNESTA · ReferencePrescription
ESZOPICLONE 1MG · TABLET · ORAL

Approval history

2019-08-18Labeling · Supplement 38 · 901 required — Letter ↗AP
2019-02-06Labeling · Supplement 37 · 901 required — Label ↗AP
2018-11-07Labeling · Supplement 36 · standard — Label ↗AP
2015-08-27Manufacturing (CMC) · Supplement 32 · standardAP
2015-02-16Manufacturing (CMC) · Supplement 27 · standardAP
2014-11-03Manufacturing (CMC) · Supplement 31 · standardAP
2014-05-29Manufacturing (CMC) · Supplement 29 · standardAP
2014-05-15Labeling · Supplement 30 · standard — Label ↗AP
2014-04-04Manufacturing (CMC) · Supplement 25 · standardAP
2014-02-03Labeling · Supplement 28 · standard — Letter ↗AP
2012-10-10Efficacy · Supplement 26 · priority — Pediatric Written Request ↗AP
2012-10-10Labeling · Supplement 24 · unknown — Letter ↗AP
2012-01-26Labeling · Supplement 21 · unknown — Letter ↗AP
2009-09-30Labeling · Supplement 15 · standardAP
2009-04-23Manufacturing (CMC) · Supplement 11AP
2009-04-06Manufacturing (CMC) · Supplement 12 — Letter ↗AP
2008-01-29Labeling · Supplement 5 · standard — Letter ↗AP
2008-01-29Labeling · Supplement 8 · standard — Letter ↗AP
2006-05-23Manufacturing (CMC) · Supplement 4AP
2004-12-15Type 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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