PRAXGEN FDA Approval ANDA 212770

ANDA 212770

PRAXGEN

FDA Drug Application

Application #212770

Application Sponsors

ANDA 212770PRAXGEN

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTIONEQ 300MG BASE/ML0LINCOMYCIN HYDROCHLORIDELINCOMYCIN HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-03-12STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

PRAXGEN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212770
            [companyName] => PRAXGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"LINCOMYCIN HYDROCHLORIDE","activeIngredients":"LINCOMYCIN HYDROCHLORIDE","strength":"EQ 300MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/12\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-12
        )

)

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