Application 074793

Type: ANDA
Sponsor: DAVA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LORAZEPAM	LORAZEPAM	INJECTABLE;INJECTION	2MG/ML	No	No
002	LORAZEPAM	LORAZEPAM	INJECTABLE;INJECTION	4MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A074793-001	LORAZEPAM	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION			2000-03-16
A074793-002	LORAZEPAM	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION			2000-03-16

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074793-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	2000-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074793-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	2000-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074793-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	2000-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074793-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	2000-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074793-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	2000-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074793-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	2000-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074793-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	2000-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074793-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	2000-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074793-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	2000-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074793-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	2000-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074793-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	2000-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074793-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	2000-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074793-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	2000-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074793-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	2000-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074793-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	2000-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074793-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	2000-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074793-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	2000-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074793-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	2000-03-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074793-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	2000-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074793-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	2000-03-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074793-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	2000-03-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074793-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	2000-03-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074793-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	2000-03-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074793-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	2000-03-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074793-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	2000-03-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074793-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	2000-03-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074793-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	2000-03-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074793-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	2000-03-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074793-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	2000-03-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074793-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	2000-03-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074793-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	2000-03-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074793-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	2000-03-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074793-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	2000-03-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074793-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	2000-03-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074793-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	2000-03-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074793-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	2000-03-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074793-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	2000-03-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074793-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	2000-03-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074793-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	2000-03-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074793-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	2000-03-16	`782e0a99824c…`

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 6 · 104 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	be9f8bda-1cd9-40a6-a4da-b5961389fb5b	2026-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	6c5356b1-c199-49ad-bb00-fd67c6691f74	2026-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	eb068a0f-5c0e-4218-b4c5-a0d0b1d362bd	2026-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	ANI Pharmaceuticals, Inc.	787240e9-67b5-4af3-b16d-7cf314e3f2e3	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Hospira, Inc.	20140b19-846b-425f-b191-670e17809945	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	d6364be4-056b-4ebe-83bc-3fc85e8f488c	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	St. Mary's Medical Park Pharmacy	56093df3-10f6-e747-e063-6294a90a6564	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	St. Mary's Medical Park Pharmacy	569e8a5a-ddf7-ebbc-e063-6294a90ab7a4	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	b707ecb2-644c-4323-ab0e-7bc5929cd560	2026-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Unit Dose Solutions, Inc.	5519bba8-9eb7-a3e0-e063-6294a90afd94	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Unit Dose Solutions, Inc.	551a1b7f-d342-2c53-e063-6394a90a9a2a	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	0cd02e52-ead5-4b2a-9708-c7c4be7b7995	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Coupler LLC	54d72943-f8d1-5a78-e063-6294a90a059b	2026-06-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Redpharm Drug	5407f327-3a22-8c15-e063-6294a90a3169	2026-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
LORAZEPAM	LORAZEPAM	REMEDYREPACK INC.	7fa1a011-5e28-4b13-bcd2-5c5fc9b663b2	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LORAZEPAM generic name: LORAZEPAM
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	ac1f88c2-2cf2-47de-a612-946cd4503090	2026-06-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
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	REMEDYREPACK INC.	5a02c97d-637d-43f7-803c-afe4381ccc59	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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
18366	ORIG	2002-01-15
30699	ORIG	2000-03-16
22371	ORIG	2000-03-16