TORRENT PHARMS LTD FDA Approval ANDA 214722

ANDA 214722

TORRENT PHARMS LTD

FDA Drug Application

Application #214722

Application Sponsors

ANDA 214722TORRENT PHARMS LTD

Marketing Status

None (Tentative Approval)001

Application Products

001GEL;TOPICAL7.5%0DAPSONEDAPSONE

FDA Submissions

UNKNOWN; ORIG1TA2021-04-23STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

TORRENT PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214722
            [companyName] => TORRENT PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAPSONE","activeIngredients":"DAPSONE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/23\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-23
        )

)

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