NDA 022352

TAKEDA PHARMS USA

FDA Drug Application

Application #022352

Documents

• Letter: 2011-07-25
• Letter: 2015-12-18
• Label: 2010-05-07
• Label: 2011-07-25
• Label: 2015-12-31
• Letter: 2009-08-06
• Letter: 2010-05-06
• Letter: 2011-07-25
• Letter: 2014-08-15
• Label: 2009-07-30
• Label: 2011-07-25
• Label: 2014-08-15
• Review: 2010-02-17
• Summary Review: 2010-02-17
• Medication Guide: 2016-12-09
• Letter: 2020-05-15
• Label: 2020-05-18
• Medication Guide: 2020-05-18

Application Sponsors

NDA 022352

TAKEDA PHARMS USA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

0.6MG

1

COLCRYS

COLCHICINE

FDA Submissions

TYPE 7; Type 7 - Drug Already Marketed without Approved NDA	ORIG	1	AP	2009-07-29	PRIORITY
LABELING; Labeling	SUPPL	4	AP	2010-04-29	UNKNOWN
REMS; REMS	SUPPL	13	AP	2011-07-20	N/A
LABELING; Labeling	SUPPL	14	AP	2011-07-20	UNKNOWN
LABELING; Labeling	SUPPL	17	AP	2014-08-14	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2013-05-15	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2013-11-25	PRIORITY
LABELING; Labeling	SUPPL	22	AP	2015-12-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2016-01-25	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2016-12-22	STANDARD
LABELING; Labeling	SUPPL	26	AP	2020-05-14	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	4	Null	7
SUPPL	13	Null	6
SUPPL	14	Null	6
SUPPL	17	Null	7
SUPPL	19	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	15
SUPPL	23	Null	0
SUPPL	26	Null	7

TE Codes

001

Prescription

AB

CDER Filings

TAKEDA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22352
            [companyName] => TAKEDA PHARMS USA
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/022352s026lbl.pdf#page=25"]
            [products] => [{"drugName":"COLCRYS","activeIngredients":"COLCHICINE","strength":"0.6MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/14\/2020","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022352s026lbl.pdf\"}]","notes":""},{"actionDate":"12\/17\/2015","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022352s022lbl.pdf\"}]","notes":""},{"actionDate":"08\/14\/2014","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022352s017lbl.pdf\"}]","notes":""},{"actionDate":"07\/20\/2011","submission":"SUPPL-14","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022352s013s014lbl.pdf\"}]","notes":""},{"actionDate":"07\/20\/2011","submission":"SUPPL-14","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022352s013s014lbl.pdf\"}]","notes":""},{"actionDate":"07\/20\/2011","submission":"SUPPL-13","supplementCategories":"REMS-Assessment","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022352s013s014lbl.pdf\"}]","notes":""},{"actionDate":"04\/29\/2010","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022352s004lbl.pdf\"}]","notes":""},{"actionDate":"04\/29\/2010","submission":"SUPPL-4","supplementCategories":"REMS-Assessment","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022352s004lbl.pdf\"}]","notes":""},{"actionDate":"04\/29\/2010","submission":"SUPPL-4","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022352s004lbl.pdf\"}]","notes":""},{"actionDate":"04\/29\/2010","submission":"SUPPL-4","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022352s004lbl.pdf\"}]","notes":""},{"actionDate":"07\/29\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022352lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"COLCRYS","submission":"COLCHICINE","actionType":"0.6MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-05-14
        )

)