ANDA 062396

HIKMA INTL PHARMS

FDA Drug Application

Application #062396

Application Sponsors

ANDA 062396

HIKMA INTL PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	EQ 100MG BASE	0	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE
002	CAPSULE;ORAL	EQ 50MG BASE	0	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE

FDA Submissions

	ORIG	1	AP	1984-11-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1989-05-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1989-12-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1989-12-05
LABELING; Labeling	SUPPL	16	AP	1993-03-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1993-06-08
LABELING; Labeling	SUPPL	18	AP	1993-08-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1994-02-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1994-03-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1995-01-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1998-05-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1998-10-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1999-11-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1999-11-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2000-10-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2000-09-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2000-09-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2001-02-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2001-01-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2001-06-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2002-03-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2002-12-09
LABELING; Labeling	SUPPL	34	AP	2003-10-24
LABELING; Labeling	SUPPL	35	AP	2004-10-04
LABELING; Labeling	SUPPL	37	AP	2006-05-08
LABELING; Labeling	SUPPL	38	AP	2007-05-31
LABELING; Labeling	SUPPL	39	AP	2008-06-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	2010-05-15
LABELING; Labeling	SUPPL	42	AP	2010-11-18
LABELING; Labeling	SUPPL	44	AP	2011-11-30
LABELING; Labeling	SUPPL	48	AP	2015-09-21	STANDARD
LABELING; Labeling	SUPPL	49	AP	2015-09-21	STANDARD
LABELING; Labeling	SUPPL	51	AP	2015-09-21	STANDARD
LABELING; Labeling	SUPPL	52	AP	2015-09-21	STANDARD
LABELING; Labeling	SUPPL	53	AP	2015-09-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	67	AP	2018-10-30	UNKNOWN

Submissions Property Types

SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	20	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
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	40	Null	7
SUPPL	44	Null	15
SUPPL	48	Null	7
SUPPL	49	Null	15
SUPPL	51	Null	7
SUPPL	52	Null	15
SUPPL	53	Null	15
SUPPL	67	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

HIKMA INTL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62396
            [companyName] => HIKMA INTL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXYCYCLINE HYCLATE","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 100MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXYCYCLINE HYCLATE","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 50MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DOXYCYCLINE HYCLATE","submission":"DOXYCYCLINE HYCLATE","actionType":"EQ 100MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DOXYCYCLINE HYCLATE","submission":"DOXYCYCLINE HYCLATE","actionType":"EQ 50MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)