ANDA 202411

HOSPIRA INC

FDA Drug Application

Application #202411

Application Sponsors

ANDA 202411

HOSPIRA INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAMUSCULAR, INTRAVENOUS

10GM/20ML (500MG/ML)

0

MAGNESIUM SULFATE

MAGNESIUM SULFATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-05-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2019-03-11	UNKNOWN

Submissions Property Types

ORIG	1	Null	1
SUPPL	2	Null	7

TE Codes

001

Prescription

AP

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202411
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MAGNESIUM SULFATE","activeIngredients":"MAGNESIUM SULFATE","strength":"10GM\/20ML (500MG\/ML)","dosageForm":"SOLUTION;INTRAMUSCULAR, INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/14\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/11\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-03-11
        )

)