Application 018140

Type: NDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ATIVAN	LORAZEPAM	INJECTABLE;INJECTION	2MG/ML	Yes	Yes
002	ATIVAN	LORAZEPAM	INJECTABLE;INJECTION	4MG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018140-001	ATIVAN	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N018140-002	ATIVAN	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N018140-001	AP
N018140-002	AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N018140-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018140-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018140-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018140-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018140-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018140-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018140-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018140-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018140-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018140-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018140-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018140-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018140-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018140-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018140-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018140-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018140-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018140-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018140-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018140-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018140-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018140-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018140-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018140-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018140-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018140-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018140-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018140-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018140-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018140-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018140-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018140-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018140-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018140-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018140-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018140-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018140-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018140-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018140-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018140-002	AP	1	`bb7c543d1eb4…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lorazepam	LORAZEPAM	Hikma Pharmaceuticals USA Inc.	4084fa74-9fd2-45ef-9d56-27bfa31d4e46	2024-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018140 application number: NDA018140 ndc (product): 0641-6050 ndc (product): 0641-6048 ndc (product): 0641-6051 ndc (product): 0641-6049
Lorazepam	LORAZEPAM	Hikma Pharmaceuticals USA Inc.	e9b54e42-04cf-4c62-90e1-36f7b31a4e81	2024-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018140 application number: NDA018140 ndc (product): 0641-6045 ndc (product): 0641-6047 ndc (product): 0641-6044 ndc (product): 0641-6046
Ativan	LORAZEPAM	Hikma Pharmaceuticals USA Inc.	5fc0e987-61c9-40c4-b0d5-fcea07c8733e	2023-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018140 application number: NDA018140 ndc (product): 0641-6001 ndc (product): 0641-6002 ndc (product): 0641-6000 ndc (product): 0641-6003
Lorazepam	LORAZEPAM	Hikma Pharmaceuticals USA Inc.	b79b38ee-c29d-4099-964f-000031f47f5a	2022-04-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018140 application number: NDA018140 ndc (product): 0641-6207
Lorazepam	LORAZEPAM	Civica, Inc.	5140798d-8571-41fb-84a4-e182aac3f64c	2021-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018140 application number: NDA018140 ndc (product): 72572-380

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0641-6000	Ativan	Lorazepam	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6000	Ativan	Lorazepam	West-Ward Pharmaceuticals Corp.	NDA	Current
0641-6000	Ativan	Lorazepam	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6000	Ativan	Lorazepam	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6001	Ativan	Lorazepam	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6001	Ativan	Lorazepam	West-Ward Pharmaceuticals Corp.	NDA	Current
0641-6001	Ativan	Lorazepam	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6001	Ativan	Lorazepam	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6002	Ativan	Lorazepam	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6002	Ativan	Lorazepam	West-Ward Pharmaceuticals Corp.	NDA	Current
0641-6002	Ativan	Lorazepam	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6002	Ativan	Lorazepam	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6003	Ativan	Lorazepam	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6003	Ativan	Lorazepam	West-Ward Pharmaceuticals Corp.	NDA	Current
0641-6003	Ativan	Lorazepam	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6003	Ativan	Lorazepam	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6044	Lorazepam	Lorazepam	West-Ward Pharmaceuticals Corp.	NDA	Current
0641-6044	Lorazepam	Lorazepam	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6045	Lorazepam	Lorazepam	West-Ward Pharmaceuticals Corp.	NDA	Current
0641-6045	Lorazepam	Lorazepam	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6046	Lorazepam	Lorazepam	West-Ward Pharmaceuticals Corp.	NDA	Current
0641-6046	Lorazepam	Lorazepam	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6047	Lorazepam	Lorazepam	West-Ward Pharmaceuticals Corp.	NDA	Current
0641-6047	Lorazepam	Lorazepam	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6048	Lorazepam	Lorazepam	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6048	Lorazepam	Lorazepam	West-Ward Pharmaceuticals Corp.	NDA	Current
0641-6049	Lorazepam	Lorazepam	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6049	Lorazepam	Lorazepam	West-Ward Pharmaceuticals Corp.	NDA	Current
0641-6050	Lorazepam	Lorazepam	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6050	Lorazepam	Lorazepam	West-Ward Pharmaceuticals Corp.	NDA	Current
0641-6051	Lorazepam	Lorazepam	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6051	Lorazepam	Lorazepam	West-Ward Pharmaceuticals Corp.	NDA	Current
0641-6207	Lorazepam	Lorazepam	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6207	Lorazepam	Lorazepam	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6207	Lorazepam	Lorazepam	West-Ward Pharmaceuticals Corp.	NDA	Current
64725-6044	Lorazepam	Lorazepam	TYA Pharmaceuticals	NDA	Current
72572-380	Lorazepam	Lorazepam	Civica, Inc.	NDA	Current
72572-380	Lorazepam	Lorazepam	Civica, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73226	SUPPL	2023-01-17
73170	SUPPL	2023-01-17
66160	SUPPL	2021-02-09
66129	SUPPL	2021-02-09
48224	SUPPL	2017-05-02
48223	SUPPL	2017-05-02
48195	SUPPL	2017-05-02
48194	SUPPL	2017-05-02
47209	SUPPL	2017-02-15
14917	SUPPL	2016-05-31
40780	SUPPL	2007-04-09
850	SUPPL	2006-12-28
11167	SUPPL	2006-12-04
20110	SUPPL	1997-10-05