ALKEM LABS LTD FDA Approval ANDA 214913

ANDA 214913

ALKEM LABS LTD

FDA Drug Application

Application #214913

Application Sponsors

ANDA 214913ALKEM LABS LTD

Marketing Status

Prescription001
Prescription002

Application Products

001FOR SOLUTION;ORALEQ 25MG BASE/ML0VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDE
002FOR SOLUTION;ORALEQ 50MG BASE/ML0VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-11-14STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ALKEM LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214913
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 25MG BASE\/ML","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 50MG BASE\/ML","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/14\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-14
        )

)

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