ANDA 215846

HAINAN POLY

FDA Drug Application

Application #215846

Documents

• Letter: 2022-09-07

Application Sponsors

ANDA 215846

HAINAN POLY

Marketing Status

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

Application Products

001	SOLUTION;INTRAVENOUS	10MG/50ML (0.2MG/ML)	0	SODIUM NITROPRUSSIDE	SODIUM NITROPRUSSIDE
002	SOLUTION;INTRAVENOUS	20MG/100ML (0.2MG/ML)	0	SODIUM NITROPRUSSIDE	SODIUM NITROPRUSSIDE
003	SOLUTION;INTRAVENOUS	50MG/100ML (0.5MG/ML)	0	SODIUM NITROPRUSSIDE	SODIUM NITROPRUSSIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-08-26

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

002	Prescription	AP
003	Prescription	AP

CDER Filings

HAINAN POLY

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215846
            [companyName] => HAINAN POLY
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM NITROPRUSSIDE","activeIngredients":"SODIUM NITROPRUSSIDE","strength":"10MG\/50ML (0.2MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SODIUM NITROPRUSSIDE","activeIngredients":"SODIUM NITROPRUSSIDE","strength":"20MG\/100ML (0.2MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SODIUM NITROPRUSSIDE","activeIngredients":"SODIUM NITROPRUSSIDE","strength":"50MG\/100ML (0.5MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/26\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-26
        )

)