ANDA 210082

DR REDDYS LABS INC

FDA Drug Application

Application #210082

Documents

• Letter: 2020-05-14

Application Sponsors

ANDA 210082

DR REDDYS LABS INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

001

TABLET; ORAL

2.5MG

0

APIXABAN

APIXABAN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-03-02

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

DR REDDYS LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210082
            [companyName] => DR REDDYS LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"APIXABAN","activeIngredients":"APIXABAN","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/02\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/210082Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-03-02
        )

)