NDA 208286

DR REDDYS LABS LTD

FDA Drug Application

Application #208286

Documents

• Letter: 2016-01-29

Application Sponsors

NDA 208286

DR REDDYS LABS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

CAPSULE;ORAL

40MG

0

ZENAVOD

DOXYCYCLINE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2016-01-27

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208286
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZENAVOD","activeIngredients":"DOXYCYCLINE","strength":"40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/27\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/208286Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-01-27
        )

)