ALEMBIC PHARMS LTD FDA Approval ANDA 215078

ANDA 215078

ALEMBIC PHARMS LTD

FDA Drug Application

Application #215078

Application Sponsors

ANDA 215078ALEMBIC PHARMS LTD

Marketing Status

Prescription001

Application Products

001SOLUTION;INHALATION0.02MG/2ML0FORMOTEROL FUMARATEFORMOTEROL FUMARATE

FDA Submissions

UNKNOWN; ORIG1AP2021-11-22STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAN

CDER Filings

ALEMBIC PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215078
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FORMOTEROL FUMARATE","activeIngredients":"FORMOTEROL FUMARATE","strength":"0.02MG\/2ML","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/22\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-11-22
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.