ANDA 203236

HOSPIRA INC

FDA Drug Application

Application #203236

Application Sponsors

ANDA 203236

HOSPIRA INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

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

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-03-30
LABELING; Labeling	SUPPL	2	AP	2020-05-29	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-05-29	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	6	Null	7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203236
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CISATRACURIUM BESYLATE","activeIngredients":"CISATRACURIUM BESYLATE","strength":"EQ 2MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CISATRACURIUM BESYLATE","activeIngredients":"CISATRACURIUM BESYLATE","strength":"EQ 10MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/30\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/29\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/29\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/29\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-05-29
        )

)