ALKEM LABS LTD FDA Approval ANDA 214554

ANDA 214554

ALKEM LABS LTD

FDA Drug Application

Application #214554

Application Sponsors

ANDA 214554ALKEM LABS LTD

Marketing Status

Prescription001

Application Products

001FOR SOLUTION;ORALEQ 3GM BASE/PACKET0FOSFOMYCIN TROMETHAMINEFOSFOMYCIN TROMETHAMINE

FDA Submissions

UNKNOWN; ORIG1AP2021-10-21STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAA

CDER Filings

ALKEM LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214554
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FOSFOMYCIN TROMETHAMINE","activeIngredients":"FOSFOMYCIN TROMETHAMINE","strength":"EQ 3GM BASE\/PACKET","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/21\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-21
        )

)

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