BEXIMCO PHARMS USA FDA Approval ANDA 202546

ANDA 202546

BEXIMCO PHARMS USA

FDA Drug Application

Application #202546

Application Sponsors

ANDA 202546BEXIMCO PHARMS USA

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004

Application Products

001TABLET;ORAL200MG0RIBAVIRINRIBAVIRIN
002TABLET;ORAL400MG0RIBAVIRINRIBAVIRIN
003TABLET;ORAL500MG0RIBAVIRINRIBAVIRIN
004TABLET;ORAL600MG0RIBAVIRINRIBAVIRIN

FDA Submissions

UNKNOWN; ORIG1AP2014-08-12

Submissions Property Types

ORIG1Null7

CDER Filings

BEXIMCO PHARMS USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202546
            [companyName] => BEXIMCO PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIBAVIRIN","activeIngredients":"RIBAVIRIN","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RIBAVIRIN","activeIngredients":"RIBAVIRIN","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RIBAVIRIN","activeIngredients":"RIBAVIRIN","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RIBAVIRIN","activeIngredients":"RIBAVIRIN","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/12\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-08-12
        )

)

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