ANDA 205442

HOSPIRA INC

FDA Drug Application

Application #205442

Application Sponsors

ANDA 205442

HOSPIRA INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

600MG/300ML (2MG/ML)

0

LINEZOLID

LINEZOLID

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-07-07	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-06-21	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001

Prescription

AP

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205442
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LINEZOLID","activeIngredients":"LINEZOLID","strength":"600MG\/300ML (2MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/07\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/21\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/21\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-06-21
        )

)