TORRENT FDA Approval ANDA 212015

ANDA 212015

TORRENT

FDA Drug Application

Application #212015

Application Sponsors

ANDA 212015TORRENT

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL250MG0ERYTHROMYCINERYTHROMYCIN
002TABLET;ORAL500MG0ERYTHROMYCINERYTHROMYCIN

FDA Submissions

UNKNOWN; ORIG1AP2020-07-06STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

TORRENT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212015
            [companyName] => TORRENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"ERYTHROMYCIN","activeIngredients":"ERYTHROMYCIN","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ERYTHROMYCIN","activeIngredients":"ERYTHROMYCIN","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-06
        )

)

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