ANDA 083365

HIKMA INTL PHARMS

FDA Drug Application

Application #083365

Application Sponsors

ANDA 083365

HIKMA INTL PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	20MG	0	HYDROCORTISONE	HYDROCORTISONE
002	TABLET;ORAL	5MG	0	HYDROCORTISONE	HYDROCORTISONE
003	TABLET;ORAL	10MG	0	HYDROCORTISONE	HYDROCORTISONE

FDA Submissions

	ORIG	1	AP	1973-06-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1982-07-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1982-07-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1985-11-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1985-11-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1988-10-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1988-10-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1986-12-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1988-10-14
LABELING; Labeling	SUPPL	19	AP	1990-04-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1988-01-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1991-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1991-04-03
LABELING; Labeling	SUPPL	24	AP	1991-03-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1994-04-22
LABELING; Labeling	SUPPL	29	AP	1994-05-23
LABELING; Labeling	SUPPL	30	AP	1995-06-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1997-11-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1998-10-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1999-01-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	2000-08-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	2002-01-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	2002-07-15
LABELING; Labeling	SUPPL	40	AP	2015-02-23
LABELING; Labeling	SUPPL	41	AP	2017-06-28	STANDARD
LABELING; Labeling	SUPPL	42	AP	2015-02-13	STANDARD
LABELING; Labeling	SUPPL	43	AP	2017-06-28	STANDARD
LABELING; Labeling	SUPPL	45	AP	2017-06-28	STANDARD
LABELING; Labeling	SUPPL	46	AP	2017-06-28	STANDARD

Submissions Property Types

SUPPL	5	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	20	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	28	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	40	Null	15
SUPPL	41	Null	7
SUPPL	42	Null	7
SUPPL	43	Null	7
SUPPL	45	Null	7
SUPPL	46	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

HIKMA INTL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83365
            [companyName] => HIKMA INTL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCORTISONE","activeIngredients":"HYDROCORTISONE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYDROCORTISONE","activeIngredients":"HYDROCORTISONE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYDROCORTISONE","activeIngredients":"HYDROCORTISONE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCORTISONE","submission":"HYDROCORTISONE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HYDROCORTISONE","submission":"HYDROCORTISONE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HYDROCORTISONE","submission":"HYDROCORTISONE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)