ANDA 065483

HOSPIRA INC

FDA Drug Application

Application #065483

Application Sponsors

ANDA 065483

HOSPIRA INC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	EQ 750MG BASE/VIAL	0	CEFUROXIME SODIUM	CEFUROXIME SODIUM
002	INJECTABLE;INJECTION	EQ 1.5GM BASE/VIAL	0	CEFUROXIME SODIUM	CEFUROXIME SODIUM

FDA Submissions

	ORIG	1	AP	2008-10-15
LABELING; Labeling	SUPPL	2	AP	2016-04-12	STANDARD

Submissions Property Types

SUPPL

2

Null

7

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65483
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFUROXIME SODIUM","activeIngredients":"CEFUROXIME SODIUM","strength":"EQ 750MG BASE\/VIAL","dosageForm":"INJECTABLE;INTRAMUSCULAR, INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CEFUROXIME SODIUM","activeIngredients":"CEFUROXIME SODIUM","strength":"EQ 1.5GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEFUROXIME SODIUM","submission":"CEFUROXIME SODIUM","actionType":"EQ 750MG BASE\/VIAL","submissionClassification":"INJECTABLE;INTRAMUSCULAR, INTRAVENOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CEFUROXIME SODIUM","submission":"CEFUROXIME SODIUM","actionType":"EQ 1.5GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)