NDA 214070

BOND AVILLION 2 DEVELOPMENT LP

FDA Drug Application

Application #214070

Documents

• Letter: 2023-01-11
• Label: 2023-01-12

Application Sponsors

NDA 214070

BOND AVILLION 2 DEVELOPMENT LP

Marketing Status

• Prescription: 001

Application Products

001

AEROSOL, METERED;INHALATION

ALBUTEROL 90MCG BUDESONIDE 80MCG

0

AIRSUPRA

ALBUTEROL AND BUDESONIDE

FDA Submissions

TYPE 4; Type 4 - New Combination

ORIG

1

AP

2023-01-10

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

BOND AVILLION 2 DEVELOPMENT LP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214070
            [companyName] => BOND AVILLION 2 DEVELOPMENT LP
            [docInserts] => ["",""]
            [products] => [{"drugName":"AIRSUPRA","activeIngredients":"ALBUTEROL SULFATE;BUDESONIDE","strength":"ALBUTEROL 90MCG BUDESONIDE 80MCG","dosageForm":"AEROSOL, METERED;INHALATION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/10\/2023","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2023\\\/214070s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/10\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2023\\\/214070s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2023\\\/214070Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2023-01-10
        )

)