Application 077754

Type: ANDA
Sponsor: OXFORD PHARMS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A077754-001	LORAZEPAM	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2006-05-10
A077754-002	LORAZEPAM	LORAZEPAM	1MG	TABLET / ORAL	AB	2006-05-10
A077754-003	LORAZEPAM	LORAZEPAM	2MG	TABLET / ORAL	AB	2006-05-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077754-001	AB
A077754-002	AB
A077754-003	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 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077754-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2006-05-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077754-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2006-05-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077754-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2006-05-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077754-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2006-05-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077754-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2006-05-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077754-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2006-05-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077754-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2006-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077754-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2006-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077754-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2006-05-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077754-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2006-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077754-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2006-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077754-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2006-05-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077754-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2006-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077754-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2006-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077754-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2006-05-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077754-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2006-05-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077754-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2006-05-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077754-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2006-05-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077754-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2006-05-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077754-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2006-05-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077754-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2006-05-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077754-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2006-05-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077754-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2006-05-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077754-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2006-05-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077754-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2006-05-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077754-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2006-05-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077754-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2006-05-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077754-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2006-05-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077754-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2006-05-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077754-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2006-05-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077754-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2006-05-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077754-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2006-05-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077754-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2006-05-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077754-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2006-05-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077754-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2006-05-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077754-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2006-05-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077754-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2006-05-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077754-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2006-05-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077754-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2006-05-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077754-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2006-05-10	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077754-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077754-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077754-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077754-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077754-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077754-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077754-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077754-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077754-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077754-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077754-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077754-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077754-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077754-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077754-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077754-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077754-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077754-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077754-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077754-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077754-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077754-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077754-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077754-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077754-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077754-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077754-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077754-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077754-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077754-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077754-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077754-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077754-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077754-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077754-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077754-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077754-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077754-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077754-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077754-001	AB	1	`301d65b070ca…`

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 5 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LORAZEPAM	LORAZEPAM	A-S Medication Solutions	8602cef8-167e-4a8c-b10f-fc3295a3abcc	2024-01-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LORAZEPAM generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	973eff80-b2cd-42ca-8e88-e0151e691e59	2024-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Clinical Solutions Wholesale, LLC	fdc11b95-2233-42b4-b5f3-9390b5e9e1b2	2024-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	0ce02d7d-d855-c73f-e063-6294a90abe93	2023-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Leading Pharma, LLC	5ca13415-4b77-4131-a9d2-6db26bc49167	2023-12-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Asclemed USA, Inc.	91da80c8-3162-43f0-b53e-897070b26a54	2023-11-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
LORAZEPAM	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	247110f2-5468-4593-8d86-41f8c869e03d	2023-10-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LORAZEPAM generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Chartwell RX, LLC	e075c78d-f0c6-4380-b769-bb8833d23ba5	2023-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
LORAZEPAM	LORAZEPAM	A-S Medication Solutions	823b1d71-a510-4d34-8015-60b55af23d78	2023-08-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LORAZEPAM generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Amneal Pharmaceuticals LLC	bf265c2e-ab2f-42e5-96cf-3998eb5a644d	2023-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	SUN PHARMACEUTICAL INDUSTRIES INC	0c1caa9c-9ef1-459c-86c3-adb939130a9f	2023-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Teva Pharmaceuticals USA, Inc.	1bf22e97-9425-484d-bac6-519c6bae6a37	2023-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Proficient Rx LP	a407d3fe-ff0f-45b0-8a1e-c7a2a11c5569	2023-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	8df3eed3-c936-4772-ab08-574c54dd8bf5	2023-01-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Pharmaceutical Associates, Inc.	711b60a3-028d-41d4-aa17-8f976e6df23e	2022-08-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Proficient Rx LP	73bf2b31-5c7e-4b3a-9e97-8304931510b0	2022-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Proficient Rx LP	5b78f7af-0ad8-4fa1-a8c0-9308fe8d9b3a	2022-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Hikma Pharmaceuticals USA Inc.	b79b38ee-c29d-4099-964f-000031f47f5a	2022-04-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	1c956cc1-9217-46e0-80a3-7c811163d3f1	2021-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Civica, Inc.	5140798d-8571-41fb-84a4-e182aac3f64c	2021-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0603-4246	Lorazepam	lorazepam	Qualitest Pharmaceuticals	ANDA	Current
0615-8003	Lorazepam	lorazepam	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8004	Lorazepam	Lorazepam	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8050	Lorazepam	Lorazepam	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
67296-1060	Lorazepam	Lorazepam	RedPharm Drug, Inc.	ANDA	Current
67296-1060	Lorazepam	Lorazepam	RedPharm Drug, Inc.	ANDA	Current