ANDA 212555

GLENMARK PHARMS LTD

FDA Drug Application

Application #212555

Documents

• Letter: 2021-07-07

Application Sponsors

ANDA 212555

GLENMARK PHARMS LTD

Marketing Status

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

Application Products

002

CAPSULE;ORAL

EQ 150MG BASE

0

NINTEDANIB

NINTEDANIB ESYLATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-06-22

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212555
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NINTEDANIB","activeIngredients":"NINTEDANIB ESYLATE","strength":"EQ 100MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"NINTEDANIB","activeIngredients":"NINTEDANIB ESYLATE","strength":"EQ 150MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/22\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/212555Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-22
        )

)