ANDA 209452

DR REDDYS LABS LTD

FDA Drug Application

Application #209452

Documents

• Letter: 2020-03-17

Application Sponsors

ANDA 209452

DR REDDYS LABS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

POWDER FOR ORAL SOLUTION

100MG/PACKET

0

SAPROPTERIN DIHYDROCHLORIDE

SAPROPTERIN DIHYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-01-28

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209452
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"SAPROPTERIN DIHYDROCHLORIDE","activeIngredients":"SAPROPTERIN DIHYDROCHLORIDE","strength":"100MG\/PACKET","dosageForm":"POWDER FOR ORAL SOLUTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/28\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209452Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-01-28
        )

)