EXELA PHARMA FDA Approval ANDA 211086

ANDA 211086

EXELA PHARMA

FDA Drug Application

Application #211086

Application Sponsors

ANDA 211086EXELA PHARMA

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTIONEQ 500MG BASE/VIAL0ERYTHROMYCIN LACTOBIONATEERYTHROMYCIN LACTOBIONATE

FDA Submissions

UNKNOWN; ORIG1AP2020-09-17STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

EXELA PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211086
            [companyName] => EXELA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ERYTHROMYCIN LACTOBIONATE","activeIngredients":"ERYTHROMYCIN LACTOBIONATE","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/17\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-17
        )

)

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