NDA 012148

ABBVIE

FDA Drug Application

Application #012148

Application Sponsors

NDA 012148

ABBVIE

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	0.125MG;25MG	0	ORETICYL 25	DESERPIDINE; HYDROCHLOROTHIAZIDE
002	TABLET;ORAL	0.25MG;25MG	0	ORETICYL FORTE	DESERPIDINE; HYDROCHLOROTHIAZIDE
003	TABLET;ORAL	0.125MG;50MG	0	ORETICYL 50	DESERPIDINE; HYDROCHLOROTHIAZIDE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1959-12-14	STANDARD
LABELING; Labeling	SUPPL	6	AP	2001-09-17
LABELING; Labeling	SUPPL	8	AP	1979-08-20
LABELING; Labeling	SUPPL	10	AP	1979-08-20
LABELING; Labeling	SUPPL	14	AP	1994-02-16
LABELING; Labeling	SUPPL	16	AP	1984-02-08
LABELING; Labeling	SUPPL	18	AP	1994-02-16
LABELING; Labeling	SUPPL	19	AP	1994-02-16

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 12148
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ORETICYL 25","activeIngredients":"DESERPIDINE; HYDROCHLOROTHIAZIDE","strength":"0.125MG;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ORETICYL 50","activeIngredients":"DESERPIDINE; HYDROCHLOROTHIAZIDE","strength":"0.125MG;50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ORETICYL FORTE","activeIngredients":"DESERPIDINE; HYDROCHLOROTHIAZIDE","strength":"0.25MG;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ORETICYL 25","submission":"DESERPIDINE; HYDROCHLOROTHIAZIDE","actionType":"0.125MG;25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ORETICYL 50","submission":"DESERPIDINE; HYDROCHLOROTHIAZIDE","actionType":"0.125MG;50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ORETICYL FORTE","submission":"DESERPIDINE; HYDROCHLOROTHIAZIDE","actionType":"0.25MG;25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)