ANDA 209040

SANDOZ INC

FDA Drug Application

Application #209040

Documents

• Letter: 2018-07-06

Application Sponsors

ANDA 209040

SANDOZ INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION;OPHTHALMIC

0.0015%

0

TAFLUPROST

TAFLUPROST

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-06-04

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AT

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209040
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TAFLUPROST","activeIngredients":"TAFLUPROST","strength":"0.0015%","dosageForm":"SOLUTION;OPHTHALMIC","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/04\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209040Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-06-04
        )

)