DR REDDYS LABS LTD FDA Approval ANDA 205376

ANDA 205376

DR REDDYS LABS LTD

FDA Drug Application

Application #205376

Application Sponsors

ANDA 205376DR REDDYS LABS LTD

Marketing Status

None (Tentative Approval)001

FDA Submissions

UNKNOWN; ORIG1TA2020-10-08STANDARD

Submissions Property Types

ORIG1Null1

CDER Filings

DR REDDYS LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205376
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"BENDAMUSTINE HYDROCHLORIDE","activeIngredients":"BENDAMUSTINE HYDROCHLORIDE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/08\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-08
        )

)

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