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 3 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lorazepam	LORAZEPAM	PD-Rx Pharmaceuticals, Inc.	7999b9c3-6185-4e4e-a4c3-d5d33d6c31d6	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	American Health Packaging	45e31a87-a8db-4dda-b94b-83535b62e8e2	2025-09-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	PD-Rx Pharmaceuticals, Inc.	08a30230-fc95-9025-e063-6394a90ae21b	2025-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Rising Pharma Holdings, Inc.	386255e2-65aa-48ce-9eb1-246f1493cc14	2025-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Preferred Pharmaceuticals, Inc.	00960fbd-a5da-408b-9867-62982f20906f	2025-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Preferred Pharmaceuticals, Inc.	6cc1f35d-ff33-404e-aa5e-b01eab89863e	2025-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Ativan	LORAZEPAM	Bausch Health US LLC	89057c93-8155-4040-acec-64e877bd2b4c	2025-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LORAZEPAM
LOREEV XR	LORAZEPAM	A-S Medication Solutions	c470fdee-8e18-4da9-b072-943d6b2518cf	2025-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	3c20c89f-c8c3-43b3-837e-da413f449795	2025-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	17919c82-87f2-5030-e063-6294a90ac91a	2025-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Golden State Medical Supply, Inc.	32fb5628-bf80-0135-e063-6294a90aa3ab	2025-04-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	1791d5c9-9004-5c4b-e063-6294a90adf3d	2025-04-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals,Inc.	8aaf9bcb-7a4e-ffaa-e053-2995a90a3913	2025-01-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
LORAZEPAM	LORAZEPAM	DirectRx	ddcc0b2b-4be2-6d18-e053-2a95a90af987	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: LORAZEPAM generic name: LORAZEPAM
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals, Inc.	4a66b854-4dd6-3746-e054-00144ff8d46c	2025-01-20	Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
LORAZEPAM	LORAZEPAM	Advanced Rx of Tennessee, LLC	2a57e549-390b-5482-e063-6394a90aeb3b	2024-12-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LORAZEPAM generic name: LORAZEPAM
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals, Inc.	29f63525-2839-946c-e063-6294a90aebb1	2024-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Fresenius Kabi USA, LLC	b2487467-a63f-48b5-b0de-3a6ce6672d50	2024-11-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals, Inc.	503834f9-fa2e-5e23-e054-00144ff88e88	2024-11-13	Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	A-S Medication Solutions	be85b116-9f09-403a-8e0d-e77e344d3a9a	2024-11-13	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