ANDA 084935

GLAXOSMITHKLINE

FDA Drug Application

Application #084935

Documents

• Other Important Information from FDA: 2007-05-18

Application Sponsors

ANDA 084935

GLAXOSMITHKLINE

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

0

DEXEDRINE

DEXTROAMPHETAMINE SULFATE

FDA Submissions

	ORIG	1	AP	1976-02-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1982-06-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1982-05-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1991-08-22
LABELING; Labeling	SUPPL	15	AP	1991-08-22
LABELING; Labeling	SUPPL	16	AP	1997-04-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1998-07-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1999-10-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2000-02-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2000-11-28
LABELING; Labeling	SUPPL	24	AP	2006-08-23
LABELING; Labeling	SUPPL	25	AP	2007-08-17

Submissions Property Types

SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	1
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84935
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXEDRINE","activeIngredients":"DEXTROAMPHETAMINE SULFATE","strength":"5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DEXEDRINE","submission":"DEXTROAMPHETAMINE SULFATE","actionType":"5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)