ANDA 212080

AKORN

FDA Drug Application

Application #212080

Documents

• Letter: 2021-03-10

Application Sponsors

ANDA 212080

AKORN

Marketing Status

• Prescription: 001

Application Products

001

GEL;OPHTHALMIC

0.5%

0

LOTEPREDNOL ETABONATE

LOTEPREDNOL ETABONATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-02-10

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212080
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOTEPREDNOL ETABONATE","activeIngredients":"LOTEPREDNOL ETABONATE","strength":"0.5%","dosageForm":"GEL;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/10\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-10
        )

)