EUGIA PHARMA FDA Approval ANDA 214632

ANDA 214632

EUGIA PHARMA

FDA Drug Application

Application #214632

Application Sponsors

ANDA 214632EUGIA PHARMA

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001POWDER;INTRAVENOUSEQ 100MG BASE/VIAL0PEMETREXED DISODIUMPEMETREXED DISODIUM
002POWDER;INTRAVENOUSEQ 500MG BASE/VIAL0PEMETREXED DISODIUMPEMETREXED DISODIUM
003POWDER;INTRAVENOUSEQ 1GM BASE/VIAL0PEMETREXED DISODIUMPEMETREXED DISODIUM

FDA Submissions

UNKNOWN; ORIG1AP2022-05-25STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP

CDER Filings

EUGIA PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214632
            [companyName] => EUGIA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEMETREXED DISODIUM","activeIngredients":"PEMETREXED DISODIUM","strength":"EQ 100MG BASE\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PEMETREXED DISODIUM","activeIngredients":"PEMETREXED DISODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PEMETREXED DISODIUM","activeIngredients":"PEMETREXED DISODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/25\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-25
        )

)

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