ANDA 065247

HOSPIRA INC

FDA Drug Application

Application #065247

Documents

• Label: 2014-02-06

Application Sponsors

ANDA 065247

HOSPIRA INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 10GM BASE/VIAL

0

CEFAZOLIN SODIUM

CEFAZOLIN SODIUM

FDA Submissions

	ORIG	1	AP	2005-08-12
LABELING; Labeling	SUPPL	6	AP	2010-06-30
LABELING; Labeling	SUPPL	10	AP	2011-08-31
LABELING; Labeling	SUPPL	11	AP	2013-01-17

Submissions Property Types

SUPPL	10	Null	15
SUPPL	11	Null	15

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65247
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFAZOLIN SODIUM","activeIngredients":"CEFAZOLIN SODIUM","strength":"EQ 10GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/17\/2013","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/065247s011lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CEFAZOLIN SODIUM","submission":"CEFAZOLIN SODIUM","actionType":"EQ 10GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2013-01-17
        )

)