ANDA 084878

HIKMA INTL PHARMS

FDA Drug Application

Application #084878

Application Sponsors

ANDA 084878

HIKMA INTL PHARMS

Marketing Status

• Prescription: 001
• Discontinued: 002

Application Products

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

FDA Submissions

	ORIG	1	AP	1977-01-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1982-08-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1983-07-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1985-12-20
LABELING; Labeling	SUPPL	24	AP	1988-11-29
LABELING; Labeling	SUPPL	25	AP	1989-04-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1992-11-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1991-03-28
BIOEQUIV; Bioequivalence	SUPPL	32	AP	1991-02-07
LABELING; Labeling	SUPPL	35	AP	1992-07-28
LABELING; Labeling	SUPPL	36	AP	2004-03-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	2006-07-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	2006-07-12
LABELING; Labeling	SUPPL	46	AP	2011-08-17
LABELING; Labeling	SUPPL	50	AP	2020-08-20	STANDARD

Submissions Property Types

SUPPL	14	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	26	Null	0
SUPPL	29	Null	0
SUPPL	32	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	46	Null	15
SUPPL	50	Null	7

TE Codes

001

Prescription

AB

CDER Filings

HIKMA INTL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84878
            [companyName] => HIKMA INTL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)