ANDA 212639

ALEMBIC PHARMS LTD

FDA Drug Application

Application #212639

Application Sponsors

ANDA 212639

ALEMBIC PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

EQ 2% BASE

0

DORZOLAMIDE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-08-09

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AT

CDER Filings

ALEMBIC PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212639
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DORZOLAMIDE HYDROCHLORIDE","activeIngredients":"DORZOLAMIDE HYDROCHLORIDE","strength":"EQ 2% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/09\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-08-09
        )

)