NDA 214408

ACCORD HLTHCARE INC

FDA Drug Application

Application #214408

Documents

• Letter: 2022-05-18
• Label: 2022-07-21

Application Sponsors

NDA 214408

ACCORD HLTHCARE INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	SOLUTION;INTRAVENOUS	100MG/4ML (25MG/ML),	0	PEMETREXED	PEMETREXED
002	SOLUTION;INTRAVENOUS	500MG/20ML (25MG/ML)	0	PEMETREXED	PEMETREXED
003	SOLUTION;INTRAVENOUS	850MG/34ML (25MG/ML)	0	PEMETREXED	PEMETREXED
004	SOLUTION;INTRAVENOUS	1000MG/40ML (25MG/ML).	0	PEMETREXED	PEMETREXED

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

TA

2022-05-17

STANDARD

Submissions Property Types

ORIG

1

Null

6

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
        )

)