NDA 019101

HIKMA

FDA Drug Application

Application #019101

Documents

• Letter: 2016-12-20
• Label: 2016-12-21
• Label: 2019-01-25
• Letter: 2019-02-13
• Letter: 2019-10-09
• Label: 2019-10-10

Application Sponsors

NDA 019101

HIKMA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 0.05MG BASE/ML

1

FENTANYL CITRATE PRESERVATIVE FREE

FENTANYL CITRATE

FDA Submissions

	ORIG	1	AP	1984-07-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1985-11-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1985-01-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1986-11-19
LABELING; Labeling	SUPPL	9	AP	1989-11-16
LABELING; Labeling	SUPPL	10	AP	1990-01-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1992-06-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1991-08-07
LABELING; Labeling	SUPPL	13	AP	1991-08-07
LABELING; Labeling	SUPPL	14	AP	1991-05-01
LABELING; Labeling	SUPPL	15	AP	1994-03-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1996-08-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1998-11-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1999-05-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2001-06-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2001-08-28
LABELING; Labeling	SUPPL	31	AP	2010-02-25
LABELING; Labeling	SUPPL	33	AP	2012-02-13
LABELING; Labeling	SUPPL	37	AP	2013-02-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	2014-03-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	2014-05-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	2015-01-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	2015-11-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	2016-02-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	2016-05-26
LABELING; Labeling	SUPPL	45	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	47	AP	2019-01-24	STANDARD
LABELING; Labeling	SUPPL	51	AP	2019-10-08	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	31	Null	7
SUPPL	33	Null	15
SUPPL	37	Null	7
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	15
SUPPL	47	Null	7
SUPPL	51	Null	15

TE Codes

001

Prescription

AP

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19101
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)