ASTRAZENECA FDA Approval NDA 021929

NDA 021929

ASTRAZENECA

FDA Drug Application

Application #021929

Documents

Letter2006-07-21
Letter2007-11-08
Letter2009-03-03
Letter2011-08-22
Label2007-11-07
Label2008-07-16
Label2009-04-03
Label2010-06-28
Other Important Information from FDA2007-02-21
Letter2007-11-08
Letter2008-07-17
Letter2011-02-18
Letter2010-06-29
Letter2012-07-25
Label2006-07-21
Label2007-11-07
Review2008-10-30
Review2012-03-02
Label2017-01-27
Letter2017-01-31
Label2017-09-12
Medication Guide2017-09-12
Letter2017-09-15
Label2017-12-21
Letter2017-12-27
Pediatric Written Request2011-01-28
Pediatric Amendment 12011-05-05
Pediatric Amendment 22012-04-06
Pediatric Amendment 32015-03-09
Pediatric Amendment 42015-10-19
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01

Application Sponsors

NDA 021929ASTRAZENECA

Marketing Status

Prescription001
Prescription002

Application Products

001AEROSOL, METERED;INHALATION0.08MG/INH;0.0045MG/INH1SYMBICORTBUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
002AEROSOL, METERED;INHALATION0.16MG/INH;0.0045MG/INH1SYMBICORTBUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2006-07-21STANDARD
LABELING; LabelingSUPPL4AP2007-10-31STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2007-10-26STANDARD
LABELING; LabelingSUPPL10AP2008-07-16STANDARD
EFFICACY; EfficacySUPPL12AP2009-02-27STANDARD
EFFICACY; EfficacySUPPL13AP2017-01-27UNKNOWN
REMS; REMSSUPPL19AP2011-02-16N/A
LABELING; LabelingSUPPL21AP2010-06-25901 ORDER
REMS; REMSSUPPL28AP2011-08-18N/A
MANUF (CMC); Manufacturing (CMC)SUPPL30AP2012-05-08N/A
REMS; REMSSUPPL33AP2012-07-23N/A
MANUF (CMC); Manufacturing (CMC)SUPPL35AP2014-01-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL36AP2014-02-27STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL37AP2014-04-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL38AP2015-04-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL39AP2014-06-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL40AP2016-06-10STANDARD
EFFICACY; EfficacySUPPL41AP2017-09-11STANDARD
EFFICACY; EfficacySUPPL42AP2017-12-20STANDARD

Submissions Property Types

SUPPL6Null0
SUPPL12Null7
SUPPL13Null8
SUPPL19Null7
SUPPL21Null7
SUPPL28Null15
SUPPL30Null15
SUPPL33Null15
SUPPL35Null0
SUPPL36Null0
SUPPL37Null0
SUPPL38Null0
SUPPL39Null0
SUPPL40Null0
SUPPL41Null15
SUPPL42Null6

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ASTRAZENECA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21929
            [companyName] => ASTRAZENECA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SYMBICORT","activeIngredients":"BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE","strength":"0.08MG\/INH;0.0045MG\/INH","dosageForm":"AEROSOL, METERED;INHALATION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"SYMBICORT","activeIngredients":"BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE","strength":"0.16MG\/INH;0.0045MG\/INH","dosageForm":"AEROSOL, METERED;INHALATION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/20\/2017","submission":"SUPPL-42","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021929s042lbl.pdf\"}]","notes":""},{"actionDate":"09\/11\/2017","submission":"SUPPL-41","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021929s041lbl.pdf\"}]","notes":""},{"actionDate":"01\/27\/2017","submission":"SUPPL-13","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021929s013lbl.pdf\"}]","notes":""},{"actionDate":"06\/25\/2010","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021929s021lbl.pdf\"}]","notes":""},{"actionDate":"02\/27\/2009","submission":"SUPPL-12","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021929s012lbl.pdf\"}]","notes":""},{"actionDate":"02\/27\/2009","submission":"SUPPL-12","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021929s012lbl.pdf\"}]","notes":""},{"actionDate":"07\/16\/2008","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021929s010lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2007","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021929s004lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2007","submission":"SUPPL-6","supplementCategories":"Manufacturing (CMC)-Control","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021929s006lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"07\/21\/2006","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021929lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"SYMBICORT","submission":"BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE","actionType":"0.08MG\/INH;0.0045MG\/INH","submissionClassification":"AEROSOL, METERED;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SYMBICORT","submission":"BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE","actionType":"0.16MG\/INH;0.0045MG\/INH","submissionClassification":"AEROSOL, METERED;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-12-20
        )

)
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