FRESENIUS KABI USA FDA Approval ANDA 212086

ANDA 212086

FRESENIUS KABI USA

FDA Drug Application

Application #212086

Application Sponsors

ANDA 212086FRESENIUS KABI USA

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTIONEQ 0.05MG BASE/ML0FENTANYL CITRATEFENTANYL CITRATE

FDA Submissions

UNKNOWN; ORIG1AP2020-09-01STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

FRESENIUS KABI USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212086
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENTANYL CITRATE","activeIngredients":"FENTANYL CITRATE","strength":"EQ 0.05MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-01
        )

)

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