ANDA 207630

AUROBINDO PHARMA LTD

FDA Drug Application

Application #207630

Documents

• Letter: 2018-08-17

Application Sponsors

ANDA 207630

AUROBINDO PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

EQ 2% BASE;EQ 0.5% BASE

0

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-07-24

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AT

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207630
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE","activeIngredients":"DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE","strength":"EQ 2% BASE;EQ 0.5% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/24\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/207630Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-07-24
        )

)