NDA 011971

ABBVIE

FDA Drug Application

Application #011971

Application Sponsors

NDA 011971

ABBVIE

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	25MG	0	ORETIC	HYDROCHLOROTHIAZIDE
002	TABLET;ORAL	50MG	0	ORETIC	HYDROCHLOROTHIAZIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1959-07-06	STANDARD
LABELING; Labeling	SUPPL	12	AP	1975-03-03	STANDARD
LABELING; Labeling	SUPPL	15	AP	1976-02-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1976-06-29	STANDARD
LABELING; Labeling	SUPPL	21	AP	1991-09-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1982-06-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1982-05-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1983-12-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1985-07-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1998-04-16	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	12	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 11971
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ORETIC","activeIngredients":"HYDROCHLOROTHIAZIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ORETIC","activeIngredients":"HYDROCHLOROTHIAZIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ORETIC","submission":"HYDROCHLOROTHIAZIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ORETIC","submission":"HYDROCHLOROTHIAZIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)