ANDA 214271

JIANGSU PHARMS

FDA Drug Application

Application #214271

Documents

• Letter: 2022-08-25

Application Sponsors

ANDA 214271

JIANGSU PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	55%	0	IODIXANOL	IODIXANOL
002	INJECTABLE;INJECTION	65.2%	0	IODIXANOL	IODIXANOL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-05-19

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

JIANGSU PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214271
            [companyName] => JIANGSU PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"IODIXANOL","activeIngredients":"IODIXANOL","strength":"55%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IODIXANOL","activeIngredients":"IODIXANOL","strength":"65.2%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/19\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-19
        )

)