DR REDDYS LABS INC FDA Approval ANDA 208541

ANDA 208541

DR REDDYS LABS INC

FDA Drug Application

Application #208541

Application Sponsors

ANDA 208541DR REDDYS LABS INC

Marketing Status

Prescription001

Application Products

001TABLET;ORAL60MG0TICAGRELORTICAGRELOR

FDA Submissions

UNKNOWN; ORIG1TA2020-10-29STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

DR REDDYS LABS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208541
            [companyName] => DR REDDYS LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TICAGRELOR","activeIngredients":"TICAGRELOR","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/29\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-29
        )

)

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