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 2 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LORAZEPAM	LORAZEPAM	Bryant Ranch Prepack	46af8e93-3169-408a-b4d8-b8498642801d	2026-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LORAZEPAM generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Preferred Pharmaceuticals Inc.	4a50329b-b272-4164-bddf-0d6cea3d7a23	2026-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Redpharm Drug	52614947-c96c-3361-e063-6394a90ae172	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	American Health Packaging	6dfbe8be-168c-44e9-acfa-fa838b92d3b7	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Bryant Ranch Prepack	11372b3d-52c0-4694-8c88-4b72d3fda9d0	2026-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Coupler LLC	51119efa-c1a3-71f0-e063-6394a90a9e2a	2026-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Coupler LLC	5114810c-025f-6113-e063-6294a90af538	2026-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Fresenius Kabi USA, LLC	462a13da-259a-40e7-bd5b-f7f42ae025b7	2026-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
LORAZEPAM	LORAZEPAM	PD-Rx Pharmaceuticals, Inc.	0418ad09-3069-4381-9a8f-e41b234fdac6	2026-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LORAZEPAM generic name: LORAZEPAM
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	1009c870-fd98-4e3b-81c8-4184036fb8c2	2026-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	A-S Medication Solutions	8361519b-be1a-4542-a782-d7cdfa153e86	2026-01-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	a0a33933-f697-4d3b-ba99-8a995a4b6c6b	2026-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
LORAZEPAM	LORAZEPAM	DIRECT RX	4832f02d-289c-2fe6-e054-00144ff8d46c	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: LORAZEPAM generic name: LORAZEPAM
LORAZEPAM	LORAZEPAM	Aurolife Pharma LLC	5b851f67-309d-4ef3-8b4b-ade8908256ea	2025-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LORAZEPAM generic name: LORAZEPAM
Lorazepam	LORAZEPAM	RedPharm Drug, Inc.	891b2c10-942f-0e4d-e053-2995a90af028	2025-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	PharmPak, Inc.	b6e4d2c7-10c0-4d77-be7b-caa3d3b86997	2025-11-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	PD-Rx Pharmaceuticals, Inc.	1f79a5a1-0c40-45cf-8994-51f5ba3a5938	2025-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
LOREEV XR	LORAZEPAM	Almatica Pharma LLC	227734c1-bf01-9607-73ea-5a1f38a89bd9	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LORAZEPAM
Lorazepam	LORAZEPAM	PD-Rx Pharmaceuticals, Inc.	0681c8db-ff09-4258-a5e0-76a26b0ea0af	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	PD-Rx Pharmaceuticals, Inc.	7afd9a59-3463-4eda-8cf3-ef90be05de3d	2025-10-08	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