Application 017794

Type: NDA
Sponsor: BAUSCH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ATIVAN	LORAZEPAM	TABLET;ORAL	0.5MG	Yes	No
002	ATIVAN	LORAZEPAM	TABLET;ORAL	1MG	Yes	No
003	ATIVAN	LORAZEPAM	TABLET;ORAL	2MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
N017794-001	ATIVAN	LORAZEPAM	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982
N017794-002	ATIVAN	LORAZEPAM	1MG	TABLET / ORAL	AB	RLD, Approved before 1982
N017794-003	ATIVAN	LORAZEPAM	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N017794-001	AB
N017794-002	AB
N017794-003	AB

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 4 of 4 · 132 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
2022-10-28 04:53 UTC	2022-10	N017794-001	ATIVAN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N017794-002	ATIVAN	1MG	TABLET / ORAL	AB	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N017794-003	ATIVAN	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017794-001	ATIVAN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N017794-002	ATIVAN	1MG	TABLET / ORAL	AB	RLD, Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N017794-003	ATIVAN	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017794-001	ATIVAN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017794-002	ATIVAN	1MG	TABLET / ORAL	AB	RLD, Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017794-003	ATIVAN	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017794-001	ATIVAN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017794-002	ATIVAN	1MG	TABLET / ORAL	AB	RLD, Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017794-003	ATIVAN	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N017794-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N017794-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N017794-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N017794-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017794-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017794-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017794-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017794-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017794-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017794-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017794-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017794-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017794-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017794-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017794-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017794-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017794-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017794-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017794-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017794-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017794-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017794-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017794-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017794-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017794-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017794-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017794-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017794-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017794-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017794-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017794-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017794-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017794-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017794-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017794-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017794-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017794-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017794-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017794-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017794-001	AB	1	`79d66fd596c7…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ativan	LORAZEPAM	Bausch Health US LLC	89057c93-8155-4040-acec-64e877bd2b4c	2025-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017794 application number: NDA017794 ndc (product): 0187-0064 ndc (product): 0187-0063 ndc (product): 0187-0065

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0187-0063	Ativan	lorazepam	Bausch Health US LLC	NDA	Current
0187-0063	Ativan	lorazepam	Bausch Health US LLC	NDA	Current
0187-0063	Ativan	lorazepam	Bausch Health US LLC	NDA	Current
0187-0063	Ativan	lorazepam	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-0063	Ativan	lorazepam	Bausch Health US LLC	NDA	Current
0187-0063	Ativan	lorazepam	Bausch Health Americas, Inc.	NDA	Current
0187-0063	Ativan	lorazepam	Bausch Health US LLC	NDA	Current
0187-0063	Ativan	lorazepam	Bausch Health US, LLC	NDA	Current
0187-0063	Ativan	lorazepam	Bausch Health US LLC	NDA	Current
0187-0063	Ativan	lorazepam	Bausch Health US LLC	NDA	Current
0187-0064	Ativan	lorazepam	Bausch Health US LLC	NDA	Current
0187-0064	Ativan	lorazepam	Bausch Health US LLC	NDA	Current
0187-0064	Ativan	lorazepam	Bausch Health US LLC	NDA	Current
0187-0064	Ativan	lorazepam	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-0064	Ativan	lorazepam	Bausch Health US LLC	NDA	Current
0187-0064	Ativan	lorazepam	Bausch Health Americas, Inc.	NDA	Current
0187-0064	Ativan	lorazepam	Bausch Health US LLC	NDA	Current
0187-0064	Ativan	lorazepam	Bausch Health US, LLC	NDA	Current
0187-0064	Ativan	lorazepam	Bausch Health US LLC	NDA	Current
0187-0064	Ativan	lorazepam	Bausch Health US LLC	NDA	Current
0187-0065	Ativan	lorazepam	Bausch Health US LLC	NDA	Current
0187-0065	Ativan	lorazepam	Bausch Health US LLC	NDA	Current
0187-0065	Ativan	lorazepam	Bausch Health US LLC	NDA	Current
0187-0065	Ativan	lorazepam	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-0065	Ativan	lorazepam	Bausch Health US LLC	NDA	Current
0187-0065	Ativan	lorazepam	Bausch Health Americas, Inc.	NDA	Current
0187-0065	Ativan	lorazepam	Bausch Health US LLC	NDA	Current
0187-0065	Ativan	lorazepam	Bausch Health US, LLC	NDA	Current
0187-0065	Ativan	lorazepam	Bausch Health US LLC	NDA	Current
0187-0065	Ativan	lorazepam	Bausch Health US LLC	NDA	Current
65084-463	Ativan	lorazepam	Mckesson Rxpak Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73225	SUPPL	2023-01-17
73224	SUPPL	2023-01-17
73168	SUPPL	2023-01-17
66184	SUPPL	2021-02-11
66183	SUPPL	2021-02-11
66127	SUPPL	2021-02-09
46629	SUPPL	2016-12-30
46462	SUPPL	2016-12-22
46238	SUPPL	2016-12-20
705	SUPPL	2007-04-25
11063	SUPPL	2007-04-20