NDA 020336

GLAXOSMITHKLINE LLC

FDA Drug Application

Application #020336

Documents

• Letter: 2005-05-20

Application Sponsors

NDA 020336

GLAXOSMITHKLINE LLC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	DYNACIRC CR	ISRADIPINE
002	TABLET, EXTENDED RELEASE;ORAL	10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	DYNACIRC CR	ISRADIPINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1994-06-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1996-01-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1997-04-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-07-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1999-12-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2002-04-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2002-06-14	STANDARD
LABELING; Labeling	SUPPL	13	AP	2005-05-18	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	13	Null	0

CDER Filings

GLAXOSMITHKLINE LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20336
            [companyName] => GLAXOSMITHKLINE LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DYNACIRC CR","activeIngredients":"ISRADIPINE","strength":"5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"DYNACIRC CR","activeIngredients":"ISRADIPINE","strength":"10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DYNACIRC CR","submission":"ISRADIPINE","actionType":"5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"DYNACIRC CR","submission":"ISRADIPINE","actionType":"10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)