ANDA 206812

JIANGSU HENGRUI MED

FDA Drug Application

Application #206812

Application Sponsors

ANDA 206812

JIANGSU HENGRUI MED

Marketing Status

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

Application Products

001	INJECTABLE;SUBCUTANEOUS	2.5MG/0.5ML	0	FONDAPARINUX SODIUM	FONDAPARINUX SODIUM
002	INJECTABLE;SUBCUTANEOUS	5MG/0.4ML	0	FONDAPARINUX SODIUM	FONDAPARINUX SODIUM
003	INJECTABLE;SUBCUTANEOUS	7.5MG/0.6ML	0	FONDAPARINUX SODIUM	FONDAPARINUX SODIUM
004	INJECTABLE;SUBCUTANEOUS	10MG/0.8ML	0	FONDAPARINUX SODIUM	FONDAPARINUX SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-05-15

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

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

CDER Filings

JIANGSU HENGRUI MED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206812
            [companyName] => JIANGSU HENGRUI MED
            [docInserts] => ["",""]
            [products] => [{"drugName":"FONDAPARINUX SODIUM","activeIngredients":"FONDAPARINUX SODIUM","strength":"2.5MG\/0.5ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FONDAPARINUX SODIUM","activeIngredients":"FONDAPARINUX SODIUM","strength":"5MG\/0.4ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FONDAPARINUX SODIUM","activeIngredients":"FONDAPARINUX SODIUM","strength":"7.5MG\/0.6ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FONDAPARINUX SODIUM","activeIngredients":"FONDAPARINUX SODIUM","strength":"10MG\/0.8ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/15\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-05-15
        )

)