ANDA 204960

JIANGSU HENGRUI MED

FDA Drug Application

Application #204960

Documents

• Letter: 2017-01-31

Application Sponsors

ANDA 204960

JIANGSU HENGRUI MED

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	EQ 2MG BASE/ML	0	CISATRACURIUM BESYLATE PRESERVATIVE FREE	CISATRACURIUM BESYLATE
002	INJECTABLE;INJECTION	EQ 10MG BASE/ML	0	CISATRACURIUM BESYLATE PRESERVATIVE FREE	CISATRACURIUM BESYLATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-01-27
LABELING; Labeling	SUPPL	8	AP	2020-07-31	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	8	Null	7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

JIANGSU HENGRUI MED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204960
            [companyName] => JIANGSU HENGRUI MED
            [docInserts] => ["",""]
            [products] => [{"drugName":"CISATRACURIUM BESYLATE PRESERVATIVE FREE","activeIngredients":"CISATRACURIUM BESYLATE","strength":"EQ 2MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CISATRACURIUM BESYLATE PRESERVATIVE FREE","activeIngredients":"CISATRACURIUM BESYLATE","strength":"EQ 10MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/27\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204960Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/31\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-07-31
        )

)