ANDA 205182

DR REDDYS LABS LTD

FDA Drug Application

Application #205182

Documents

• Letter: 2020-09-22

Application Sponsors

ANDA 205182

DR REDDYS LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION; INJECTION

24MG/2.1ML

0

PLERIXAFOR

PLERIXAFOR

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-08-10

STANDARD

Submissions Property Types

ORIG

1

Null

42

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205182
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PLERIXAFOR","activeIngredients":"PLERIXAFOR","strength":"24MG\/2.1ML","dosageForm":"SOLUTION; INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/10\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/205182Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-10
        )

)