SUN PHARM INDS LTD FDA Approval ANDA 214384

ANDA 214384

SUN PHARM INDS LTD

FDA Drug Application

Application #214384

Application Sponsors

ANDA 214384SUN PHARM INDS LTD

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002
None (Tentative Approval)003

Application Products

001CAPSULE;ORAL100MG0DROXIDOPADROXIDOPA
002CAPSULE;ORAL200MG0DROXIDOPADROXIDOPA
003CAPSULE;ORAL300MG0DROXIDOPADROXIDOPA

FDA Submissions

UNKNOWN; ORIG1TA2020-12-08STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

SUN PHARM INDS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214384
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DROXIDOPA","activeIngredients":"DROXIDOPA","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/08\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-08
        )

)

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