Application 070357

Type: ANDA
Sponsor: ROXANE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIAZEPAM	DIAZEPAM	TABLET;ORAL	5MG	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
A070357-001	DIAZEPAM	DIAZEPAM	5MG	TABLET / ORAL			1986-06-17

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	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070357-001	DIAZEPAM	5MG	TABLET / ORAL	1986-06-17	`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 5 · 89 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diazepam	DIAZEPAM	NuCare Pharmaceuticals,Inc.	859461ea-5861-8185-e053-2991aa0a954a	2024-06-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	NuCare Pharmaceuticals,Inc.	8b3cc5c9-91bd-7467-e053-2a95a90a44b8	2024-06-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Bryant Ranch Prepack	6abedac6-5133-47b2-a0e3-e239e0a2254b	2024-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Chartwell RX, LLC	6cb19468-be02-4219-9e80-94a28e2317b9	2024-05-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Alembic Pharmaceuticals Inc.	6b6ca65b-4ede-47b9-bbf3-05bb67c0c71d	2024-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Alembic Pharmaceuticals Limited	1632f040-3b2c-43da-a42f-f2baf5ec778a	2024-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Hikma Pharmaceuticals USA Inc.	2719720b-4918-4f08-b1de-b267f404505f	2024-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Bryant Ranch Prepack	04cc10ad-7d5c-434e-9b29-85b14071492b	2024-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Bryant Ranch Prepack	078bbb41-7e3a-48db-87f0-ec6a6ec0194e	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Bryant Ranch Prepack	e8e4d5f5-3b4c-4c0f-a818-9da86389473c	2024-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	A-S Medication Solutions	af9a7906-4dca-4c1f-b16b-9b666a86b363	2024-02-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Teva Pharmaceuticals USA, Inc.	48aa32cb-047a-414a-822e-82a5f26d8817	2024-01-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Clinical Solutions Wholesale, LLC	8b4946b3-ae6c-4174-bbd8-0b8ed2c8fdf3	2024-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Clinical Solutions Wholesale, LLC	83c1f93b-0fc6-4512-9c8f-9167b217d7f9	2024-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Clinical Solutions Wholesale, LLC	87b0fbb9-0c05-4ab0-8efe-7ffcae85b868	2024-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Hospira, Inc.	41044928-dd1f-40bf-1fa6-709dff559124	2024-01-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Oceanside Pharmaceuticals	b1b2848b-b265-4f6f-9141-bf106dec0726	2024-01-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Meridian Medical Technologies LLC	fa352464-14c8-49e9-b8b7-5a968b1cfa93	2023-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
DIAZEPAM	DIAZEPAM	Aurobindo Pharma Limited	2f799120-0d08-47cd-8183-a98f0267c845	2023-12-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DIAZEPAM generic name: DIAZEPAM
Diazepam	DIAZEPAM	Bryant Ranch Prepack	f2fc6f38-d627-4fb3-9be2-5e119ee7e1e1	2023-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.