NDA 022268

NOVARTIS

FDA Drug Application

Application #022268

Documents

• Letter: 2009-04-14
• Letter: 2010-02-23
• Letter: 2012-08-07
• Letter: 2013-05-01
• Label: 2010-02-23
• Label: 2012-08-07
• Review: 2009-07-08
• Summary Review: 2009-07-08
• Letter: 2015-03-20
• Label: 2009-04-16
• Label: 2013-05-01
• Label: 2015-03-20
• Label: 2018-01-09
• Letter: 2018-01-10
• Label: 2019-08-06
• Letter: 2019-08-06

Application Sponsors

NDA 022268

NOVARTIS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

20MG;120MG

1

COARTEM

ARTEMETHER; LUMEFANTRINE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2009-04-07	PRIORITY
LABELING; Labeling	SUPPL	3	AP	2012-08-06	STANDARD
LABELING; Labeling	SUPPL	4	AP	2013-04-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2013-04-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2013-04-05	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2013-11-18	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2014-04-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2014-05-06	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2014-08-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2015-01-20	PRIORITY
LABELING; Labeling	SUPPL	12	AP	2015-03-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2015-09-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2016-01-06	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2016-06-01	PRIORITY
LABELING; Labeling	SUPPL	19	AP	2018-01-08	STANDARD
LABELING; Labeling	SUPPL	21	AP	2019-08-05	STANDARD

Submissions Property Types

ORIG	1	Null	2
SUPPL	3	Null	7
SUPPL	4	Null	15
SUPPL	5	Null	14
SUPPL	6	Null	14
SUPPL	7	Null	14
SUPPL	8	Null	14
SUPPL	9	Null	14
SUPPL	10	Null	14
SUPPL	11	Null	14
SUPPL	12	Null	6
SUPPL	13	Null	14
SUPPL	14	Null	14
SUPPL	16	Null	14
SUPPL	19	Null	31
SUPPL	21	Null	7

CDER Filings

NOVARTIS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22268
            [companyName] => NOVARTIS
            [docInserts] => ["",""]
            [products] => [{"drugName":"COARTEM","activeIngredients":"ARTEMETHER; LUMEFANTRINE","strength":"20MG;120MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/05\/2019","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022268s021lbl.pdf\"}]","notes":""},{"actionDate":"01\/08\/2018","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022268s019lbl.pdf\"}]","notes":""},{"actionDate":"03\/19\/2015","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022268s012lbl.pdf\"}]","notes":""},{"actionDate":"04\/29\/2013","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022268s004lbl.pdf\"}]","notes":""},{"actionDate":"08\/06\/2012","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022268s003lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2010","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022268s001lbl.pdf\"}]","notes":""},{"actionDate":"04\/07\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022268lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"COARTEM","submission":"ARTEMETHER; LUMEFANTRINE","actionType":"20MG;120MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-08-05
        )

)