ANDA 214440

GLENMARK PHARMS LTD

FDA Drug Application

Application #214440

Application Sponsors

ANDA 214440

GLENMARK PHARMS LTD

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-01-14

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214440
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"REGADENOSON","activeIngredients":"REGADENOSON","strength":"0.4MG\/5ML(0.08MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/14\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-01-14
        )

)