AMNEAL FDA Approval ANDA 210047

ANDA 210047

AMNEAL

FDA Drug Application

Application #210047

Application Sponsors

ANDA 210047AMNEAL

Marketing Status

Prescription001

Application Products

001POWDER;INTRAVENOUSEQ 500MG BASE/VIAL0PEMETREXED DISODIUMPEMETREXED DISODIUM

FDA Submissions

UNKNOWN; ORIG1AP2022-08-04STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

AMNEAL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210047
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEMETREXED DISODIUM","activeIngredients":"PEMETREXED DISODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PEMETREXED DISODIUM","submission":"PEMETREXED DISODIUM","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"POWDER;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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