ANDA 065369

HOSPIRA INC

FDA Drug Application

Application #065369

Documents

• Letter: 2007-07-23
• Review: 2007-06-18

Application Sponsors

ANDA 065369

HOSPIRA INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	0	CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE
002	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	0	CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE
003	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	0	CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2007-06-18
LABELING; Labeling	SUPPL	2	AP	2008-02-07
LABELING; Labeling	SUPPL	4	AP	2008-05-27
LABELING; Labeling	SUPPL	10	AP	2011-09-29

Submissions Property Types

ORIG	1	Null	1
SUPPL	10	Null	15

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65369
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFEPIME HYDROCHLORIDE","activeIngredients":"CEFEPIME HYDROCHLORIDE","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CEFEPIME HYDROCHLORIDE","activeIngredients":"CEFEPIME HYDROCHLORIDE","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CEFEPIME HYDROCHLORIDE","activeIngredients":"CEFEPIME HYDROCHLORIDE","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEFEPIME HYDROCHLORIDE","submission":"CEFEPIME HYDROCHLORIDE","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CEFEPIME HYDROCHLORIDE","submission":"CEFEPIME HYDROCHLORIDE","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CEFEPIME HYDROCHLORIDE","submission":"CEFEPIME HYDROCHLORIDE","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)