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 5 of 5 · 89 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diazepam	DIAZEPAM	American Health Packaging	aeadf0b0-918b-40e0-a5e8-60b2fcbd5ded	2023-08-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Medical Purchasing Solutions, LLC	c8e979a8-af6b-f0c4-e053-2995a90ae63f	2023-05-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Medical Purchasing Solutions, LLC	c8e95ff5-c177-1ec3-e053-2995a90a6d78	2023-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	9cf031ae-d59b-430d-9b15-415ae2e49c98	2022-09-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Proficient Rx LP	f8d26f65-a015-4bfc-b1fa-8595d72af48c	2022-08-01	Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Proficient Rx LP	e7542d46-2586-4225-b07d-2633116bfa0a	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Pharmaceutical Associates, Inc.	b24f1eb7-3dab-4183-b81f-f86ac62aedd8	2021-09-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	bdb8feda-01c6-45bd-bd66-97196ccce70c	2019-05-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	b29916fb-1781-4112-9c3e-45478754d638	2017-11-28	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.