NDA 011949

SHIRE LLC

FDA Drug Application

Application #011949

Application Sponsors

NDA 011949

SHIRE LLC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

50MG

1

SALURON

HYDROFLUMETHIAZIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1959-07-22	STANDARD
LABELING; Labeling	SUPPL	9	AP	1977-04-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1978-04-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1981-01-30	STANDARD
LABELING; Labeling	SUPPL	12	AP	1979-12-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1986-11-14	STANDARD
LABELING; Labeling	SUPPL	14	AP	1980-05-06
LABELING; Labeling	SUPPL	15	AP	1985-07-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1983-11-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1983-11-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1985-03-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1983-11-07	STANDARD
LABELING; Labeling	SUPPL	20	AP	1984-01-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1984-06-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1985-03-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1986-07-28	STANDARD
LABELING; Labeling	SUPPL	24	AP	1988-12-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1996-06-24	STANDARD

Submissions Property Types

SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	25	Null	0

CDER Filings

SHIRE LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 11949
            [companyName] => SHIRE LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SALURON","activeIngredients":"HYDROFLUMETHIAZIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SALURON","submission":"HYDROFLUMETHIAZIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)