ACCORD HLTHCARE INC FDA Approval NDA 214408

NDA 214408

ACCORD HLTHCARE INC

FDA Drug Application

Application #214408

Documents

Letter2022-05-18

Application Sponsors

NDA 214408ACCORD HLTHCARE INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001SOLUTION;INTRAVENOUS100MG/4ML (25MG/ML),0PEMETREXEDPEMETREXED
002SOLUTION;INTRAVENOUS500MG/20ML (25MG/ML)0PEMETREXEDPEMETREXED
003SOLUTION;INTRAVENOUS850MG/34ML (25MG/ML)0PEMETREXEDPEMETREXED
004SOLUTION;INTRAVENOUS1000MG/40ML (25MG/ML).0PEMETREXEDPEMETREXED

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1TA2022-05-17STANDARD

Submissions Property Types

ORIG1Null6

CDER Filings

ACCORD HLTHCARE INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214408
            [companyName] => ACCORD HLTHCARE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEMETREXED","activeIngredients":"PEMETREXED","strength":"100MG\/4ML (25MG\/ML),","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PEMETREXED","activeIngredients":"PEMETREXED","strength":"500MG\/20ML (25MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PEMETREXED","activeIngredients":"PEMETREXED","strength":"850MG\/34ML (25MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PEMETREXED","activeIngredients":"PEMETREXED","strength":"1000MG\/40ML (25MG\/ML).","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/17\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/214408Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-17
        )

)

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