ANDA 215078

ALEMBIC PHARMS LTD

FDA Drug Application

Application #215078

Application Sponsors

ANDA 215078

ALEMBIC PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INHALATION

0.02MG/2ML

0

FORMOTEROL FUMARATE

FORMOTEROL FUMARATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-11-22

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AN

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
        )

)