ANDA 202495

HOSPIRA INC

FDA Drug Application

Application #202495

Application Sponsors

ANDA 202495

HOSPIRA INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1MEQ/ML

0

SODIUM BICARBONATE

SODIUM BICARBONATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-03-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2021-06-14	UNKNOWN

Submissions Property Types

ORIG	1	Null	1
SUPPL	9	Null	15

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202495
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM BICARBONATE","activeIngredients":"SODIUM BICARBONATE","strength":"1MEQ\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/06\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-03-06
        )

)