ANDA 215304

JIANGSU HENGRUI MED

FDA Drug Application

Application #215304

Application Sponsors

ANDA 215304

JIANGSU HENGRUI MED

Marketing Status

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

Application Products

001	SOLUTION;INTRAVENOUS	1.8845GM/5ML (376.9MG/ML)	0	GADOTERATE MEGLUMINE	GADOTERATE MEGLUMINE
002	SOLUTION;INTRAVENOUS	3.769GM/10ML (376.9MG/ML)	0	GADOTERATE MEGLUMINE	GADOTERATE MEGLUMINE
003	SOLUTION;INTRAVENOUS	5.6535GM/15ML (376.9MG/ML)	0	GADOTERATE MEGLUMINE	GADOTERATE MEGLUMINE
004	SOLUTION;INTRAVENOUS	7.538GM/20ML (376.9MG/ML)	0	GADOTERATE MEGLUMINE	GADOTERATE MEGLUMINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-04-11

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

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

CDER Filings

JIANGSU HENGRUI MED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215304
            [companyName] => JIANGSU HENGRUI MED
            [docInserts] => ["",""]
            [products] => [{"drugName":"GADOTERATE MEGLUMINE","activeIngredients":"GADOTERATE MEGLUMINE","strength":"1.8845GM\/5ML (376.9MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GADOTERATE MEGLUMINE","activeIngredients":"GADOTERATE MEGLUMINE","strength":"3.769GM\/10ML (376.9MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GADOTERATE MEGLUMINE","activeIngredients":"GADOTERATE MEGLUMINE","strength":"5.6535GM\/15ML (376.9MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GADOTERATE MEGLUMINE","activeIngredients":"GADOTERATE MEGLUMINE","strength":"7.538GM\/20ML (376.9MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/11\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-11
        )

)