Lorazepam Injection

Brand(s): Ativan
Category(s): prescription
SPL Type(s): Human Prescription
Master SPL: West-Ward Pharmaceuticals Corp. (2011-12-06)
Oldest Current Product: 1980-07-01
License(s): NDA, ANDA

RxNORM: INJECTION\LORAZEPAM
FDAOB: INJECTION\INJECTION\LORAZEPAM\rdfq
SPL Active: INTRAMUSCULAR\INJECTION, SOLUTION\LORAZEPAM
INTRAMUSCULAR\INJECTION\LORAZEPAM
SPL Moiety: INTRAMUSCULAR\INJECTION, SOLUTION\LORAZEPAM
INTRAMUSCULAR\INJECTION\LORAZEPAM

product(s) by strength(s)

1 ml lorazepam 2 mg/ml injection

original product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	006416001	Ativan	NDA	West-Ward Pharmaceuticals Corp.	1980-07-25	LORAZEPAM	INTRAMUSCULAR	INJECTION	NDA018140	5fc0e987-61c9-40c4-b0d5-fcea07c8733e
2	006416048		NDA	West-Ward Pharmaceuticals Corp.	1980-07-25	LORAZEPAM	INTRAMUSCULAR	INJECTION	NDA018140	4084fa74-9fd2-45ef-9d56-27bfa31d4e46

generic product(s)(s)

#	id	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	004096778	ANDA	Hospira, Inc.	1994-05-27	LORAZEPAM	INTRAMUSCULAR	INJECTION, SOLUTION	ANDA074282	608a0345-fc9c-4170-4f8d-96dbdd7e566a
2	174780040	ANDA	Akorn	1980-07-01	LORAZEPAM	INTRAMUSCULAR	INJECTION	ANDA075025	b5b17cde-a94c-4105-871c-54e7d2bd47e8

invalid application product(s)

#	id	category	labeler	first marketed	active ingredient(s)	route	dose form	equivalent product	application	spl
1	548683566	ANDA	Physicians Total Care, Inc.	2007-01-10	LORAZEPAM	INTRAMUSCULAR	INJECTION, SOLUTION	004091985	ANDA074300	9f495605-0959-442c-8636-9c2d2f93bdff

relabeler product(s)(s)

#	id	category	labeler	first marketed	active ingredient(s)	route	dose form	equivalent product	application	spl
1	647256044	NDA	Tya Pharmaceuticals	1980-07-25	LORAZEPAM	INTRAMUSCULAR	INJECTION	006416044	NDA018140	a3e2fbad-d850-4bac-9a45-dc1e75e37cab

1 ml lorazepam 4 mg/ml injection

original product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	006416003	Ativan	NDA	West-Ward Pharmaceuticals Corp.	1980-07-25	LORAZEPAM	INTRAMUSCULAR	INJECTION	NDA018140	5fc0e987-61c9-40c4-b0d5-fcea07c8733e
2	006416045		NDA	West-Ward Pharmaceuticals Corp.	1980-07-25	LORAZEPAM	INTRAMUSCULAR	INJECTION	NDA018140	e9b54e42-04cf-4c62-90e1-36f7b31a4e81

generic product(s)(s)

#	id	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	004096779	ANDA	Hospira, Inc.	1994-05-27	LORAZEPAM	INTRAMUSCULAR	INJECTION, SOLUTION	ANDA074282	608a0345-fc9c-4170-4f8d-96dbdd7e566a

application(s)

#	id	title	deprecated	applicant	approved	approved drug	in other drug docs
1	ANDA074243	LORAZEPAM		HOSPIRA INC	1994-04-12	ANDA074243_001, ANDA074243_002	Lorazepam Injectable Solution Lorazepam Cartridge
2	ANDA074276	LORAZEPAM	True	WATSON LABORATORIES INC	1994-04-15	ANDA074276_001, ANDA074276_002	Lorazepam Injectable Solution Lorazepam Cartridge
3	ANDA074280	LORAZEPAM	True	HOSPIRA INC	1994-05-27	ANDA074280_001, ANDA074280_002	Lorazepam Injectable Solution Lorazepam Cartridge
4	ANDA074282	LORAZEPAM		HOSPIRA INC	1994-05-27	ANDA074282_001, ANDA074282_002	Lorazepam Injectable Solution Lorazepam Cartridge
5	ANDA074300	LORAZEPAM	True	HOSPIRA INC	1994-04-12	ANDA074300_001, ANDA074300_003	Lorazepam Injectable Solution Lorazepam Cartridge
6	ANDA074496	LORAZEPAM	True	HIKMA MAPLE LTD	1998-09-28	ANDA074496_001, ANDA074496_002	Lorazepam Injectable Solution Lorazepam Cartridge
7	ANDA074535	LORAZEPAM	True	WATSON LABORATORIES INC	1996-09-12	ANDA074535_001, ANDA074535_002	Lorazepam Injectable Solution Lorazepam Cartridge
8	ANDA074551	LORAZEPAM	True	WATSON LABORATORIES INC	1996-09-12	ANDA074551_001, ANDA074551_002, ANDA074551_003	Lorazepam Injectable Solution Lorazepam Cartridge
9	ANDA074793	LORAZEPAM	True	DAVA PHARMACEUTICALS INC	2000-03-16	ANDA074793_001, ANDA074793_002	Lorazepam Injectable Solution Lorazepam Cartridge
10	ANDA074974	LORAZEPAM	True	AKORN INC	1998-07-23	ANDA074974_001	Lorazepam Injectable Solution Lorazepam Cartridge
11	ANDA075025	LORAZEPAM		AKORN INC	1998-07-23	ANDA075025_001	Lorazepam Injectable Solution Lorazepam Cartridge
12	ANDA076150	LORAZEPAM		INTERNATIONAL MEDICATION SYSTEMS LTD	2004-11-15	ANDA076150_001	Lorazepam Injectable Solution Lorazepam Cartridge
13	ANDA077074	LORAZEPAM PRESERVATIVE FREE		BEDFORD LABORATORIES	2005-07-13	ANDA077074_001, ANDA077074_002	Lorazepam Injectable Solution Lorazepam Cartridge
14	ANDA077076	LORAZEPAM	True	BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC	2005-07-13	ANDA077076_001, ANDA077076_002	Lorazepam Injectable Solution Lorazepam Cartridge
15	NDA018140	ATIVAN		EUROHEALTH INTERNATIONAL SARL		NDA018140_001, NDA018140_002	Lorazepam Injectable Solution Lorazepam Cartridge

application drug(s)

#	id	category/deprecated	ingredient strength(s)	dose form	rld	TE	approved	application
1	ANDA074243_001	RX	LORAZEPAM (2MG/ML)	INJECTION	False	AP	1994-04-12	LORAZEPAM
2	ANDA074243_002	RX	LORAZEPAM (4MG/ML)	INJECTION	False	AP	1994-04-12	LORAZEPAM
3	ANDA074276_001	discontinued	LORAZEPAM (2MG/ML)	INJECTION	False		1994-04-15	LORAZEPAM
4	ANDA074276_002	discontinued	LORAZEPAM (4MG/ML)	INJECTION	False		1994-04-15	LORAZEPAM
5	ANDA074280_001	discontinued	LORAZEPAM (2MG/ML)	INJECTION	False		1994-05-27	LORAZEPAM
6	ANDA074280_002	discontinued	LORAZEPAM (4MG/ML)	INJECTION	False		1994-05-27	LORAZEPAM
7	ANDA074282_001	RX	LORAZEPAM (2MG/ML)	INJECTION	False	AP	1994-05-27	LORAZEPAM
8	ANDA074282_002	RX	LORAZEPAM (4MG/ML)	INJECTION	False	AP	1994-05-27	LORAZEPAM
9	ANDA074300_001	discontinued	LORAZEPAM (2MG/ML)	INJECTION	False		1994-04-12	LORAZEPAM
10	ANDA074300_003	discontinued	LORAZEPAM (4MG/ML)	INJECTION	False		1997-03-19	LORAZEPAM
11	ANDA074496_001	discontinued	LORAZEPAM (2MG/ML)	INJECTION	False		1998-09-28	LORAZEPAM
12	ANDA074496_002	discontinued	LORAZEPAM (4MG/ML)	INJECTION	False		1998-09-28	LORAZEPAM
13	ANDA074535_001	discontinued	LORAZEPAM (2MG/ML)	INJECTION	False		1996-09-12	LORAZEPAM
14	ANDA074535_002	discontinued	LORAZEPAM (4MG/ML)	INJECTION	False		1996-09-12	LORAZEPAM
15	ANDA074551_001	discontinued	LORAZEPAM (2MG/ML)	INJECTION	False		1996-09-12	LORAZEPAM
16	ANDA074551_002	discontinued	LORAZEPAM (4MG/ML)	INJECTION	False		1996-09-12	LORAZEPAM
17	ANDA074551_003	discontinued	LORAZEPAM (1MG/0.5ML)	INJECTION	False		1996-09-12	LORAZEPAM
18	ANDA074793_001	discontinued	LORAZEPAM (2MG/ML)	INJECTION	False		2000-03-16	LORAZEPAM
19	ANDA074793_002	discontinued	LORAZEPAM (4MG/ML)	INJECTION	False		2000-03-16	LORAZEPAM
20	ANDA074974_001	discontinued	LORAZEPAM (2MG/ML)	INJECTION	False		1998-07-23	LORAZEPAM
21	ANDA075025_001	RX	LORAZEPAM (2MG/ML)	INJECTION	False	AP	1998-07-23	LORAZEPAM
22	ANDA076150_001	RX	LORAZEPAM (2MG/ML)	INJECTION	False	AP	2004-11-15	LORAZEPAM
23	ANDA077074_001	RX	LORAZEPAM (2MG/ML)	INJECTION	False	AP	2005-07-13	LORAZEPAM PRESERVATIVE FREE
24	ANDA077074_002	RX	LORAZEPAM (4MG/ML)	INJECTION	False	AP	2005-07-13	LORAZEPAM PRESERVATIVE FREE
25	ANDA077076_001	discontinued	LORAZEPAM (2MG/ML)	INJECTION	False		2005-07-13	LORAZEPAM
26	ANDA077076_002	discontinued	LORAZEPAM (4MG/ML)	INJECTION	False		2005-07-13	LORAZEPAM
27	NDA018140_001	RX	LORAZEPAM (2MG/ML)	INJECTION	True	AP		ATIVAN
28	NDA018140_002	RX	LORAZEPAM (4MG/ML)	INJECTION	True	AP		ATIVAN

spl(s)

#	id	title	category	type	labeler	labeler act	last update	version	product(s)	in other drug docs
1	4084fa74-9fd2-45ef-9d56-27bfa31d4e46 (view SPL)	Lorazepam Injection, USP	prescription	Human Prescription	West-Ward Pharmaceuticals Corp.	ANALYSIS, LABEL, MANUFACTURE	2011-12-06	1	006416048, 006416049, 006416050, 006416051	Lorazepam Injectable Solution
2	5fc0e987-61c9-40c4-b0d5-fcea07c8733e (view SPL)	ATIVANInjection (lorazepam injection, USP)	prescription	Human Prescription	West-Ward Pharmaceuticals Corp.		2011-11-16	2	006416001, 006416003, 006416000, 006416002	Lorazepam Injectable Solution
3	608a0345-fc9c-4170-4f8d-96dbdd7e566a (view SPL)	LORAZEPAMInjection, USP	prescription	Human Prescription	Hospira, Inc.		2012-07-10	11	004096778, 004096779, 004096780, 004096781	Lorazepam Injectable Solution
4	9f495605-0959-442c-8636-9c2d2f93bdff (view SPL)		prescription	Human Prescription	Physicians Total Care, Inc.	relabel	2010-06-18	1	548683566
5	a3e2fbad-d850-4bac-9a45-dc1e75e37cab (view SPL)	Lorazepam Injection, USP	prescription	Human Prescription	Tya Pharmaceuticals	RELABEL, REPACK	2011-11-15	2	647256044
6	b5b17cde-a94c-4105-871c-54e7d2bd47e8 (view SPL)	LORAZEPAM INJECTION, USP	prescription	Human Prescription	Akorn	ANALYSIS, MANUFACTURE, REPACK	2014-11-04	2	174780040
7	e9b54e42-04cf-4c62-90e1-36f7b31a4e81 (view SPL)	Lorazepam Injection, USP	prescription	Human Prescription	West-Ward Pharmaceuticals Corp.		2011-11-15	2	006416045, 006416044, 006416046, 006416047	Lorazepam Injectable Solution

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII