ANDA 209051

MICRO LABS

FDA Drug Application

Application #209051

Documents

• Letter: 2019-09-27

Application Sponsors

ANDA 209051

MICRO LABS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.0015%

0

TAFLUPROST

TAFLUPROST

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-08-19

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AT

CDER Filings

MICRO LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209051
            [companyName] => MICRO LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TAFLUPROST","activeIngredients":"TAFLUPROST","strength":"0.0015%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/19\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209051Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-08-19
        )

)