← FDA DRUG APPROVALS

FDA NDA · NDA021782

ROZEREM

ramelteon

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA021782
TYPE
NDA
ORIGINAL APPROVAL
2005-07-22
LATEST ACTION
2021-11-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ROZEREM · ReferencePrescription
RAMELTEON 8MG · TABLET · ORAL

Approval history

2021-11-03Labeling · Supplement 22 · standard — Letter ↗AP
2018-12-21Labeling · Supplement 21 · standard — Label ↗AP
2016-07-13Manufacturing (CMC) · Supplement 17 · standardAP
2013-06-14Manufacturing (CMC) · Supplement 16 · standardAP
2012-03-01Labeling · Supplement 14 · standard — Letter ↗AP
2012-03-01Labeling · Supplement 6 · standard — Letter ↗AP
2012-02-21Labeling · Supplement 12 · standard — Letter ↗AP
2011-08-04REMS · Supplement 15 — Letter ↗AP
2010-11-09Labeling · Supplement 11 · standard — Label ↗AP
2008-10-20Efficacy · Supplement 9 · unknown — Label ↗AP
2008-10-20Efficacy · Supplement 8 · unknown — Letter ↗AP
2008-10-20Efficacy · Supplement 10 · unknown — Label ↗AP
2005-08-18Labeling · Supplement 1 · standard — Label ↗AP
2005-07-22Type 1 - New Molecular Entity · Original · standard — Label ↗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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