DR REDDYS LABS LTD FDA Approval ANDA 213210

ANDA 213210

DR REDDYS LABS LTD

FDA Drug Application

Application #213210

Application Sponsors

ANDA 213210DR REDDYS LABS LTD

Marketing Status

None (Tentative Approval)001

Application Products

001SOLUTION;INTRAVENOUS0.4MG/5ML (0.08MG/ML)0REGADENOSONREGADENOSON

FDA Submissions

UNKNOWN; ORIG1TA2021-01-15UNKNOWN

Submissions Property Types

ORIG1Null31

CDER Filings

DR REDDYS LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213210
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"REGADENOSON","activeIngredients":"REGADENOSON","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/15\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"UNKNOWN","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-15
        )

)

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