ANDA 065231

HOSPIRA INC

FDA Drug Application

Application #065231

Documents

• Other Important Information from FDA: 2008-09-19

Application Sponsors

ANDA 065231

HOSPIRA INC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	0	CEFTRIAXONE	CEFTRIAXONE SODIUM
002	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	0	CEFTRIAXONE	CEFTRIAXONE SODIUM

FDA Submissions

	ORIG	1	AP	2005-08-02
LABELING; Labeling	SUPPL	7	AP	2008-11-14
LABELING; Labeling	SUPPL	10	AP	2008-11-14
LABELING; Labeling	SUPPL	11	AP	2009-08-27
LABELING; Labeling	SUPPL	12	AP	2009-08-27
LABELING; Labeling	SUPPL	13	AP	2010-08-31
LABELING; Labeling	SUPPL	14	AP	2011-04-20

Submissions Property Types

SUPPL	11	Null	7
SUPPL	12	Null	7
SUPPL	13	Null	7

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65231
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFTRIAXONE","activeIngredients":"CEFTRIAXONE SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CEFTRIAXONE","activeIngredients":"CEFTRIAXONE SODIUM","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEFTRIAXONE","submission":"CEFTRIAXONE SODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CEFTRIAXONE","submission":"CEFTRIAXONE SODIUM","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)