ANDA 208158

BAUSCH

FDA Drug Application

Application #208158

Documents

• Letter: 2020-10-30

Application Sponsors

ANDA 208158

BAUSCH

Marketing Status

• Over-the-counter: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

EQ 0.035% BASE

0

ALAWAY

KETOTIFEN FUMARATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-09-24

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

BAUSCH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208158
            [companyName] => BAUSCH
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALAWAY","activeIngredients":"KETOTIFEN FUMARATE","strength":"EQ 0.035% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/24\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-24
        )

)