ANDA 078577

HOSPIRA INC

FDA Drug Application

Application #078577

Documents

• Letter: 2015-08-13

Application Sponsors

ANDA 078577

HOSPIRA INC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	EQ 500MG/20ML (EQ 25MG/ML)	0	LEVOFLOXACIN	LEVOFLOXACIN
002	INJECTABLE;INJECTION	EQ 750MG/30ML (EQ 25MG/ML)	0	LEVOFLOXACIN	LEVOFLOXACIN

FDA Submissions

ORIG

1

AP

2015-08-12

Submissions Property Types

ORIG

1

Null

15

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78577
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"EQ 500MG\/20ML (EQ 25MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"EQ 750MG\/30ML (EQ 25MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEVOFLOXACIN","submission":"LEVOFLOXACIN","actionType":"EQ 500MG\/20ML (EQ 25MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LEVOFLOXACIN","submission":"LEVOFLOXACIN","actionType":"EQ 750MG\/30ML (EQ 25MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)