ANDA 208678

PAR PHARM INC

FDA Drug Application

Application #208678

Documents

• Letter: 2018-12-20

Application Sponsors

ANDA 208678

PAR PHARM INC

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

0.6MG

0

COLCHICINE

COLCHICINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-11-29

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

PAR PHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208678
            [companyName] => PAR PHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"COLCHICINE","activeIngredients":"COLCHICINE","strength":"0.6MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/29\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208678Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-29
        )

)