ANDA 204936

APOTEX

FDA Drug Application

Application #204936

Documents

• Letter: 2015-04-22

Application Sponsors

ANDA 204936

APOTEX

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

2015-04-17

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AT2

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204936
            [companyName] => APOTEX
            [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":"04\/17\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204936Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-04-17
        )

)