NDA 022217

NOVARTIS

FDA Drug Application

Application #022217

Documents

• Letter: 2009-10-26
• Letter: 2010-08-09
• Letter: 2011-02-14
• Letter: 2011-05-05
• Label: 2011-02-11
• Letter: 2011-10-17
• Letter: 2012-01-30
• Letter: 2012-02-06
• Letter: 2012-04-27
• Label: 2009-09-21
• Label: 2010-08-10
• Label: 2011-05-05
• Label: 2011-10-20
• Label: 2012-02-07
• Label: 2012-02-06
• Label: 2012-04-26
• Review: 2010-05-06
• Summary Review: 2010-05-06

Application Sponsors

NDA 022217

NOVARTIS

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	EQ 150MG BASE;160MG	0	VALTURNA	ALISKIREN HEMIFUMARATE; VALSARTAN
002	TABLET;ORAL	EQ 300MG BASE;320MG	0	VALTURNA	ALISKIREN HEMIFUMARATE; VALSARTAN

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2009-09-16	STANDARD
LABELING; Labeling	SUPPL	5	AP	2010-08-04	STANDARD
LABELING; Labeling	SUPPL	7	AP	2011-02-10	STANDARD
LABELING; Labeling	SUPPL	13	AP	2011-05-04	STANDARD
LABELING; Labeling	SUPPL	14	AP	2011-10-13	STANDARD
LABELING; Labeling	SUPPL	16	AP	2012-01-26	STANDARD
LABELING; Labeling	SUPPL	17	AP	2012-02-02	STANDARD
LABELING; Labeling	SUPPL	20	AP	2012-04-25	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	20	Null	0

CDER Filings

NOVARTIS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22217
            [companyName] => NOVARTIS
            [docInserts] => ["",""]
            [products] => [{"drugName":"VALTURNA","activeIngredients":"ALISKIREN HEMIFUMARATE; VALSARTAN","strength":"EQ 150MG BASE;160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VALTURNA","activeIngredients":"ALISKIREN HEMIFUMARATE; VALSARTAN","strength":"EQ 300MG BASE;320MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/25\/2012","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022217s020lbl.pdf\"}]","notes":""},{"actionDate":"02\/02\/2012","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022217s017lbl.pdf\"}]","notes":""},{"actionDate":"01\/26\/2012","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022217s016lbl.pdf\"}]","notes":""},{"actionDate":"10\/13\/2011","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022217s014lbl.pdf\"}]","notes":""},{"actionDate":"05\/04\/2011","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022217s013lbl.pdf\"}]","notes":""},{"actionDate":"02\/10\/2011","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022217s007lbl.pdf\"}]","notes":""},{"actionDate":"08\/04\/2010","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022217s005lbl.pdf\"}]","notes":""},{"actionDate":"09\/16\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022217lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"VALTURNA","submission":"ALISKIREN HEMIFUMARATE; VALSARTAN","actionType":"EQ 150MG BASE;160MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"VALTURNA","submission":"ALISKIREN HEMIFUMARATE; VALSARTAN","actionType":"EQ 300MG BASE;320MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2012-04-25
        )

)