NDA 022383

NOVARTIS

FDA Drug Application

Application #022383

Documents

• Letter: 2011-07-07
• Letter: 2012-09-27
• Letter: 2012-12-26
• Medication Guide: 2011-07-05
• Summary Review: 2011-08-12
• Letter: 2012-12-26
• Label: 2011-07-05
• Label: 2012-09-26
• Review: 2011-08-12
• Label: 2019-05-30
• Letter: 2019-06-04
• Letter: 2021-08-02
• Letter: 2021-08-02
• Label: 2021-08-03
• Label: 2021-08-03

Application Sponsors

NDA 022383

NOVARTIS

Marketing Status

• Discontinued: 001

Application Products

001

POWDER;INHALATION

EQ 75MCG BASE

1

ARCAPTA NEOHALER

INDACATEROL MALEATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2011-07-01	STANDARD
LABELING; Labeling	SUPPL	2	AP	2012-09-26	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2013-02-25	STANDARD
LABELING; Labeling	SUPPL	4	AP	2012-12-18	STANDARD
REMS; REMS	SUPPL	5	AP	2012-12-18	N/A
LABELING; Labeling	SUPPL	7	AP	2019-05-29	STANDARD
LABELING; Labeling	SUPPL	9	AP	2021-07-30	STANDARD
LABELING; Labeling	SUPPL	10	AP	2021-07-30	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	6
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	15
SUPPL	7	Null	7
SUPPL	9	Null	7
SUPPL	10	Null	31

CDER Filings

NOVARTIS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22383
            [companyName] => NOVARTIS
            [docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2011\/022383s000MedG.pdf"]
            [products] => [{"drugName":"ARCAPTA NEOHALER","activeIngredients":"INDACATEROL MALEATE","strength":"EQ 75MCG BASE","dosageForm":"POWDER;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"07\/30\/2021","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/022383s009s010lbl.pdf\"}]","notes":""},{"actionDate":"07\/30\/2021","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/022383s009s010lbl.pdf\"}]","notes":""},{"actionDate":"05\/29\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022383s007lbl.pdf\"}]","notes":""},{"actionDate":"09\/26\/2012","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022383s002lbl.pdf\"}]","notes":""},{"actionDate":"07\/01\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022383s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ARCAPTA NEOHALER","submission":"INDACATEROL MALEATE","actionType":"EQ 75MCG BASE","submissionClassification":"POWDER;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2021-07-30
        )

)