ANDA 207685

DR REDDYS LABS INC

FDA Drug Application

Application #207685

Documents

• Letter: 2019-01-23

Application Sponsors

ANDA 207685

DR REDDYS LABS INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

100MG

0

SAPROPTERIN DIHYDROCHLORIDE

SAPROPTERIN DIHYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-12-17

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

DR REDDYS LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207685
            [companyName] => DR REDDYS LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SAPROPTERIN DIHYDROCHLORIDE","activeIngredients":"SAPROPTERIN DIHYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/17\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/207685Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-12-17
        )

)