NDA 012524

ABBVIE

FDA Drug Application

Application #012524

Application Sponsors

NDA 012524

ABBVIE

Marketing Status

• Discontinued: 001
• Discontinued: 004

Application Products

001	TABLET;ORAL	2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	ENDURON	METHYCLOTHIAZIDE
004	TABLET;ORAL	5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	ENDURON	METHYCLOTHIAZIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1960-10-21	STANDARD
LABELING; Labeling	SUPPL	26	AP	1981-06-15	STANDARD
LABELING; Labeling	SUPPL	27	AP	1981-06-15	STANDARD
LABELING; Labeling	SUPPL	29	AP	1988-07-26	STANDARD
LABELING; Labeling	SUPPL	30	AP	1982-06-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1984-01-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1986-08-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1998-04-16	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	34	Null	0

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 12524
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENDURON","activeIngredients":"METHYCLOTHIAZIDE","strength":"2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ENDURON","activeIngredients":"METHYCLOTHIAZIDE","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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ENDURON","submission":"METHYCLOTHIAZIDE","actionType":"2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ENDURON","submission":"METHYCLOTHIAZIDE","actionType":"5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)