PAR PHARM INC FDA Approval ANDA 203976

ANDA 203976

PAR PHARM INC

FDA Drug Application

Application #203976

Application Sponsors

ANDA 203976PAR PHARM INC

Marketing Status

None (Tentative Approval)001

Application Products

001TABLET;ORAL0.6MG0COLCHICINECOLCHICINE

FDA Submissions

UNKNOWN; ORIG1TA2015-02-12

Submissions Property Types

ORIG1Null1

TE Codes

001PrescriptionAB

CDER Filings

PAR PHARM INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203976
            [companyName] => PAR PHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"COLCHICINE","activeIngredients":"COLCHICINE","strength":"0.6MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/12\/2015","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-02-12
        )

)

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