ANDA 215061

HENGRUI PHARMA

FDA Drug Application

Application #215061

Documents

• Letter: 2022-12-20

Application Sponsors

ANDA 215061

HENGRUI PHARMA

Marketing Status

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

Application Products

001	SOLUTION;INTRAVENOUS	1.20944GM/2ML (604.72MG/ML)	0	GADOBUTROL	GADOBUTROL
002	SOLUTION;INTRAVENOUS	4.5354GM/7.5ML (604.72MG/ML)	0	GADOBUTROL	GADOBUTROL
003	SOLUTION;INTRAVENOUS	6.0472GM/10ML (604.72MG/ML)	0	GADOBUTROL	GADOBUTROL
004	SOLUTION;INTRAVENOUS	9.0708GM/15ML (604.72MG/ML)	0	GADOBUTROL	GADOBUTROL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-11-17

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP
004	Prescription	AP

CDER Filings

HENGRUI PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215061
            [companyName] => HENGRUI PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"GADOBUTROL","activeIngredients":"GADOBUTROL","strength":"1.20944GM\/2ML (604.72MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GADOBUTROL","activeIngredients":"GADOBUTROL","strength":"4.5354GM\/7.5ML (604.72MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GADOBUTROL","activeIngredients":"GADOBUTROL","strength":"6.0472GM\/10ML (604.72MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GADOBUTROL","activeIngredients":"GADOBUTROL","strength":"9.0708GM\/15ML (604.72MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/17\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-17
        )

)