ANDA 206066

APOTEX

FDA Drug Application

Application #206066

Documents

• Letter: 2019-04-24

Application Sponsors

ANDA 206066

APOTEX

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

1.5%

0

BEPOTASTINE BESILATE

BEPOTASTINE BESILATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-03-05

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AT

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206066
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"BEPOTASTINE BESILATE","activeIngredients":"BEPOTASTINE BESILATE","strength":"1.5%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/05\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/206066Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-03-05
        )

)