NDA 212122

ASTRAZENECA AB

FDA Drug Application

Application #212122

Documents

• Letter: 2020-07-24
• Label: 2020-07-27
• Review: 2021-07-01

Application Sponsors

NDA 212122

ASTRAZENECA AB

Marketing Status

• Prescription: 001

Application Products

001

AEROSOL, METERED;INHALATION

160MCG/INH; 4.8 MCG/INH; 9MCG/INH

2

BREZTRI AEROSPHERE

BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-07-23

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

TBD

CDER Filings

ASTRAZENECA AB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212122
            [companyName] => ASTRAZENECA AB
            [docInserts] => ["",""]
            [products] => [{"drugName":"BREZTRI AEROSPHERE","activeIngredients":"BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE","strength":"160MCG\/INH; 4.8 MCG\/INH; 9MCG\/INH","dosageForm":"AEROSOL, METERED;INHALATION","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"07\/23\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212122s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/23\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212122s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212122Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-07-23
        )

)