NDA 021782

TAKEDA PHARMS USA

FDA Drug Application

Application #021782

Documents

• Letter: 2005-07-26
• Letter: 2012-03-05
• Letter: 2008-10-23
• Letter: 2008-10-23
• Letter: 2012-03-05
• Label: 2008-11-07
• Label: 2008-11-07
• Medication Guide: 2010-11-12
• Other Important Information from FDA: 2005-08-30
• Letter: 2005-08-23
• Letter: 2008-10-23
• Letter: 2010-11-15
• Letter: 2012-03-05
• Letter: 2011-08-05
• Label: 2005-07-26
• Label: 2005-08-23
• Label: 2008-11-07
• Label: 2010-11-12
• Review: 2005-10-20
• Label: 2018-12-26
• Medication Guide: 2018-12-26
• Letter: 2018-12-30
• Letter: 2021-11-05
• Label: 2021-11-05
• Medication Guide: 2021-11-05

Application Sponsors

NDA 021782

TAKEDA PHARMS USA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

8MG

1

ROZEREM

RAMELTEON

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2005-07-22	STANDARD
LABELING; Labeling	SUPPL	6	AP	2012-03-01	STANDARD
EFFICACY; Efficacy	SUPPL	8	AP	2008-10-20	UNKNOWN
EFFICACY; Efficacy	SUPPL	9	AP	2008-10-20	UNKNOWN
EFFICACY; Efficacy	SUPPL	10	AP	2008-10-20	UNKNOWN
LABELING; Labeling	SUPPL	11	AP	2010-11-09	STANDARD
LABELING; Labeling	SUPPL	12	AP	2012-02-21	STANDARD
LABELING; Labeling	SUPPL	14	AP	2012-03-01	STANDARD
REMS; REMS	SUPPL	15	AP	2011-08-04	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2013-06-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2016-07-13	STANDARD
LABELING; Labeling	SUPPL	21	AP	2018-12-21	STANDARD
LABELING; Labeling	SUPPL	22	AP	2021-11-03	STANDARD

Submissions Property Types

SUPPL	6	Null	6
SUPPL	8	Null	7
SUPPL	9	Null	6
SUPPL	10	Null	6
SUPPL	11	Null	7
SUPPL	12	Null	0
SUPPL	14	Null	7
SUPPL	15	Null	7
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	21	Null	6
SUPPL	22	Null	7

TE Codes

001

Prescription

AB

CDER Filings

TAKEDA PHARMS USA

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(
    [0] => Array
        (
            [ApplNo] => 21782
            [companyName] => TAKEDA PHARMS USA
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/021782s021lbl.pdf#page=16"]
            [products] => [{"drugName":"ROZEREM","activeIngredients":"RAMELTEON","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/21\/2018","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021782s021lbl.pdf\"}]","notes":""},{"actionDate":"11\/09\/2010","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021782s011lbl.pdf\"}]","notes":""},{"actionDate":"10\/20\/2008","submission":"SUPPL-10","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021782s008s009s010lbl.pdf\"}]","notes":""},{"actionDate":"10\/20\/2008","submission":"SUPPL-9","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021782s008s009s010lbl.pdf\"}]","notes":""},{"actionDate":"10\/20\/2008","submission":"SUPPL-8","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021782s008s009s010lbl.pdf\"}]","notes":""},{"actionDate":"10\/20\/2008","submission":"SUPPL-8","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021782s008s009s010lbl.pdf\"}]","notes":""},{"actionDate":"08\/18\/2005","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021782s001lbl.pdf\"}]","notes":""},{"actionDate":"07\/22\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021782lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ROZEREM","submission":"RAMELTEON","actionType":"8MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-12-21
        )

)