ANDA 203182

FRESENIUS KABI USA

FDA Drug Application

Application #203182

Application Sponsors

ANDA 203182

FRESENIUS KABI USA

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

2015-02-26

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203182
            [companyName] => FRESENIUS KABI USA
            [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":"02\/26\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/24\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-06-24
        )

)