Rozerem

NDA 21782, held by Takeda Pharms USA. Ramelteon.

First approved: Jul 22, 2005
Review: Standard
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Oct 20, 2008	Supplement 10Efficacy (new indication or use)	Approved	Label Letter
Oct 20, 2008	Supplement 9Efficacy (new indication or use)	Approved	Label Letter
Oct 20, 2008	Supplement 8Efficacy (new indication or use)	Approved	Label Letter
Jul 22, 2005	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Rozerem8MG · tablet;oral	Ramelteon	Rx · reference drug

All 14 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 3, 2021	Supplement 22Labeling · Standard review	Approved	Letter Label Medication Guide
Dec 21, 2018	Supplement 21Labeling · Standard review	Approved	Letter Label
Jul 13, 2016	Supplement 17Manufacturing · Standard review	Approved	None posted
Jun 14, 2013	Supplement 16Manufacturing · Standard review	Approved	None posted
Mar 1, 2012	Supplement 14Labeling · Standard review	Approved	Letter
Mar 1, 2012	Supplement 6Labeling · Standard review	Approved	Letter
Feb 21, 2012	Supplement 12Labeling · Standard review	Approved	Letter
Aug 4, 2011	Supplement 15REMS	Approved	Letter
Nov 9, 2010	Supplement 11Labeling · Standard review	Approved	Letter Label
Oct 20, 2008	Supplement 10Efficacy (new indication or use)	Approved	Label Letter
Oct 20, 2008	Supplement 9Efficacy (new indication or use)	Approved	Label Letter
Oct 20, 2008	Supplement 8Efficacy (new indication or use)	Approved	Label Letter
Aug 18, 2005	Supplement 1Labeling · Standard review	Approved	Letter Label
Jul 22, 2005	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21782
Drugs@FDA: Overview at FDA
Company: Takeda Pharmaceuticals USA

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters