ANDA 062223

GLAXOSMITHKLINE

FDA Drug Application

Application #062223

Application Sponsors

ANDA 062223

GLAXOSMITHKLINE

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	FOR SUSPENSION;ORAL	EQ 125MG BASE/5ML	0	TOTACILLIN	AMPICILLIN/AMPICILLIN TRIHYDRATE
002	FOR SUSPENSION;ORAL	EQ 250MG BASE/5ML	0	TOTACILLIN	AMPICILLIN/AMPICILLIN TRIHYDRATE

FDA Submissions

	ORIG	1	AP	1979-08-27
LABELING; Labeling	SUPPL	3	AP	1991-11-08
LABELING; Labeling	SUPPL	4	AP	2000-12-28

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62223
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOTACILLIN","activeIngredients":"AMPICILLIN\/AMPICILLIN TRIHYDRATE","strength":"EQ 125MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TOTACILLIN","activeIngredients":"AMPICILLIN\/AMPICILLIN TRIHYDRATE","strength":"EQ 250MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TOTACILLIN","submission":"AMPICILLIN\/AMPICILLIN TRIHYDRATE","actionType":"EQ 125MG BASE\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TOTACILLIN","submission":"AMPICILLIN\/AMPICILLIN TRIHYDRATE","actionType":"EQ 250MG BASE\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)