NDA 209259

SUN PHARM INDS LTD

FDA Drug Application

Application #209259

Documents

• Letter: 2017-04-27

Application Sponsors

NDA 209259

SUN PHARM INDS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

40MG

0

XYROSA

DOXYCYCLINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

TA

2017-04-26

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209259
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"XYROSA","activeIngredients":"DOXYCYCLINE","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/26\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209259Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-04-26
        )

)