FRESENIUS KABI USA FDA Approval ANDA 216145

ANDA 216145

FRESENIUS KABI USA

FDA Drug Application

Application #216145

Documents

Letter2023-01-10

Application Sponsors

ANDA 216145FRESENIUS KABI USA

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001SOLUTION;INTRAVENOUSEQ 10MG BASE/10ML (EQ 1MG BASE/ML)0ZINC SULFATEZINC SULFATE MONOHYDRATE
002SOLUTION;INTRAVENOUSEQ 25MG BASE/5ML (EQ 5MG BASE/ML)0ZINC SULFATEZINC SULFATE MONOHYDRATE
003SOLUTION;INTRAVENOUSEQ 30MG BASE/10ML (EQ 3MG BASE/ML)0ZINC SULFATEZINC SULFATE MONOHYDRATE

FDA Submissions

UNKNOWN; ORIG1AP2022-12-27STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP

CDER Filings

FRESENIUS KABI USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216145
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZINC SULFATE","activeIngredients":"ZINC SULFATE MONOHYDRATE","strength":"EQ 10MG BASE\/10ML (EQ 1MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZINC SULFATE","activeIngredients":"ZINC SULFATE MONOHYDRATE","strength":"EQ 25MG BASE\/5ML (EQ 5MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZINC SULFATE","activeIngredients":"ZINC SULFATE MONOHYDRATE","strength":"EQ 30MG BASE\/10ML (EQ 3MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/27\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-12-27
        )

)

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