ORANGE FDA Approval ANDA 213628

ANDA 213628

ORANGE

FDA Drug Application

Application #213628

Application Sponsors

ANDA 213628ORANGE

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL250MG0ERYTHROMYCINERYTHROMYCIN
002TABLET;ORAL500MG0ERYTHROMYCINERYTHROMYCIN

FDA Submissions

UNKNOWN; ORIG1AP2021-06-28STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ORANGE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213628
            [companyName] => ORANGE
            [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":"06\/28\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-28
        )

)

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