Application 074648

Type: ANDA
Sponsor: ROXANE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LORAZEPAM	LORAZEPAM	SOLUTION;ORAL	0.5MG/5ML	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074648-001	LORAZEPAM	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL			1997-03-18

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074648-001	LORAZEPAM	0.5MG/5ML	SOLUTION / ORAL	1997-03-18	`f41ea6bd6efb…`

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 4 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lorazepam	LORAZEPAM	Chartwell RX, LLC	6b0619c5-b9e9-47e7-97b5-7e581e67cf5f	2024-11-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Asclemed USA, Inc.	ebdf72f7-7462-4b83-81b4-c7988860c728	2024-11-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals,Inc.	8fa33078-c379-41f5-e053-2995a90acced	2024-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals, Inc.	4a66b854-4dc1-3746-e054-00144ff8d46c	2024-10-08	Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Bryant Ranch Prepack	853c762d-0772-4f02-99ca-0bc2911f09f0	2024-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals, Inc.	4ab77192-8fe9-2965-e054-00144ff88e88	2024-07-19	Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals,Inc.	a4fe8df0-3ce8-b8b8-e053-2995a90a28f4	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals, Inc.	50379c41-2676-590c-e054-00144ff8d46c	2024-07-08	Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	1bcf608a-11c1-ec7d-e063-6394a90ab710	2024-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals,Inc.	8aace309-f3ef-6aef-e053-2995a90aa197	2024-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals,Inc.	933b5ef3-ec29-1a96-e053-2995a90a2d33	2024-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Bryant Ranch Prepack	aac672f9-0ba7-4852-b8a7-caac9e4b1e77	2024-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Proficient Rx LP	e9052b38-3c9f-4c84-9a0d-98bd99b9ddfd	2024-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	e563594e-212c-4f31-92ea-294aeab45df3	2024-04-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Hikma Pharmaceuticals USA Inc.	4084fa74-9fd2-45ef-9d56-27bfa31d4e46	2024-04-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Hikma Pharmaceuticals USA Inc.	e9b54e42-04cf-4c62-90e1-36f7b31a4e81	2024-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Bryant Ranch Prepack	ba34ddd2-9a47-48bf-8e55-f05e9085e5a8	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Bryant Ranch Prepack	8e3d44fb-24b7-4552-9e95-de3bf871a88b	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	International Medication Systems, Limited	7dda070d-7809-46c4-8592-eb4e4c509707	2024-03-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	82f79757-69f0-4a37-93a6-55b66ae86ad7	2024-02-06	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.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22348	ORIG	2011-03-10