HIKMA FDA Approval ANDA 203300

ANDA 203300

HIKMA

FDA Drug Application

Application #203300

Application Sponsors

ANDA 203300HIKMA

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTIONEQ 500MG BASE/VIAL0VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDE
002INJECTABLE;INJECTIONEQ 1GM BASE/VIAL0VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-08-11

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

HIKMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203300
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/11\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-11
        )

)

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