ANDA 209334

JIANGSU HENGRUI MED

FDA Drug Application

Application #209334

Application Sponsors

ANDA 209334

JIANGSU HENGRUI MED

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 2MG BASE/ML

0

CISATRACURIUM BESYLATE

CISATRACURIUM BESYLATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-08-30	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-07-31	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	7

TE Codes

001

Prescription

AP

CDER Filings

JIANGSU HENGRUI MED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209334
            [companyName] => JIANGSU HENGRUI MED
            [docInserts] => ["",""]
            [products] => [{"drugName":"CISATRACURIUM BESYLATE","activeIngredients":"CISATRACURIUM BESYLATE","strength":"EQ 2MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/30\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/31\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-07-31
        )

)