ANDA 212291

AKORN INC

FDA Drug Application

Application #212291

Documents

• Letter: 2020-10-30

Application Sponsors

ANDA 212291

AKORN INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

EQ 0.5% BASE

0

TIMOLOL MALEATE

TIMOLOL MALEATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-09-11

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AT3

CDER Filings

AKORN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212291
            [companyName] => AKORN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TIMOLOL MALEATE","activeIngredients":"TIMOLOL MALEATE","strength":"EQ 0.5% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/11\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-11
        )

)