ANDA 083902

GLAXOSMITHKLINE

FDA Drug Application

Application #083902

Documents

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

Application Sponsors

ANDA 083902

GLAXOSMITHKLINE

Marketing Status

• Discontinued: 001

Application Products

001

ELIXIR;ORAL

5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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	2	AP	1998-08-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1999-10-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-11-28

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83902
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXEDRINE","activeIngredients":"DEXTROAMPHETAMINE SULFATE","strength":"5MG\/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"ELIXIR;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DEXEDRINE","submission":"DEXTROAMPHETAMINE SULFATE","actionType":"5MG\/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"ELIXIR;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)