ANDA 210560

ALEMBIC PHARMS LTD

FDA Drug Application

Application #210560

Application Sponsors

ANDA 210560

ALEMBIC PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

EQ 0.09% ACID

0

BROMFENAC SODIUM

BROMFENAC SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-06-21

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AT2

CDER Filings

ALEMBIC PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210560
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"BROMFENAC SODIUM","activeIngredients":"BROMFENAC SODIUM","strength":"EQ 0.09% ACID","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/21\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-06-21
        )

)