ANDA 064033

GLAXOSMITHKLINE

FDA Drug Application

Application #064033

Application Sponsors

ANDA 064033

GLAXOSMITHKLINE

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 1GM BASE/VIAL

0

CEFAZOLIN SODIUM

CEFAZOLIN SODIUM

FDA Submissions

	ORIG	1	AP	1993-10-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1996-05-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-05-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2002-07-31
LABELING; Labeling	SUPPL	7	AP	2005-01-28

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	6	Null	0

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 64033
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFAZOLIN SODIUM","activeIngredients":"CEFAZOLIN SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEFAZOLIN SODIUM","submission":"CEFAZOLIN SODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)