ANDA 214615

APOTEX

FDA Drug Application

Application #214615

Application Sponsors

ANDA 214615

APOTEX

Marketing Status

• Over-the-counter: 001

Application Products

001

SPRAY, METERED;NASAL

0.055MG/SPRAY

0

0

TRIAMCINOLONE ACETONIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2023-01-19

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214615
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIAMCINOLONE ACETONIDE","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.055MG\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/19\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-19
        )

)