ANDA 078815

HOSPIRA INC

FDA Drug Application

Application #078815

Documents

• Review: 2013-04-23

Application Sponsors

ANDA 078815

HOSPIRA INC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INTRAVENOUS	50MG/VIAL	0	OXALIPLATIN	OXALIPLATIN
002	INJECTABLE;INTRAVENOUS	100MG/VIAL	0	OXALIPLATIN	OXALIPLATIN

FDA Submissions

	ORIG	1	AP	2009-09-30
LABELING; Labeling	SUPPL	2	AP	2016-06-24	STANDARD
LABELING; Labeling	SUPPL	3	AP	2016-06-24	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	15

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78815
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXALIPLATIN","activeIngredients":"OXALIPLATIN","strength":"50MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXALIPLATIN","activeIngredients":"OXALIPLATIN","strength":"100MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OXALIPLATIN","submission":"OXALIPLATIN","actionType":"50MG\/VIAL","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"OXALIPLATIN","submission":"OXALIPLATIN","actionType":"100MG\/VIAL","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)