Application 013263

Type: NDA
Sponsor: ROCHE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	VALIUM	DIAZEPAM	TABLET;ORAL	2MG	Yes	No
004	VALIUM	DIAZEPAM	TABLET;ORAL	5MG	Yes	No
006	VALIUM	DIAZEPAM	TABLET;ORAL	10MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	RLD / RS
N013263-002	VALIUM	DIAZEPAM	2MG	TABLET / ORAL	AB	RLD, Approved before 1982
N013263-004	VALIUM	DIAZEPAM	5MG	TABLET / ORAL	AB	RLD, Approved before 1982
N013263-006	VALIUM	DIAZEPAM	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N013263-002	AB
N013263-004	AB
N013263-006	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 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N013263-004	VALIUM	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N013263-006	VALIUM	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N013263-002	VALIUM	2MG	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N013263-004	VALIUM	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N013263-006	VALIUM	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N013263-002	VALIUM	2MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N013263-004	VALIUM	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N013263-006	VALIUM	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N013263-002	VALIUM	2MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N013263-004	VALIUM	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N013263-006	VALIUM	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N013263-002	VALIUM	2MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N013263-004	VALIUM	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N013263-006	VALIUM	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N013263-002	VALIUM	2MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N013263-004	VALIUM	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N013263-006	VALIUM	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N013263-002	VALIUM	2MG	TABLET / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N013263-004	VALIUM	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N013263-006	VALIUM	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N013263-002	VALIUM	2MG	TABLET / ORAL	AB	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N013263-004	VALIUM	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N013263-006	VALIUM	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N013263-002	VALIUM	2MG	TABLET / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N013263-004	VALIUM	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N013263-006	VALIUM	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N013263-002	VALIUM	2MG	TABLET / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N013263-004	VALIUM	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N013263-006	VALIUM	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N013263-002	VALIUM	2MG	TABLET / ORAL	AB	RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N013263-004	VALIUM	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N013263-006	VALIUM	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N013263-002	VALIUM	2MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N013263-004	VALIUM	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N013263-006	VALIUM	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N013263-002	VALIUM	2MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N013263-004	VALIUM	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N013263-006	VALIUM	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N013263-002	VALIUM	2MG	TABLET / ORAL	AB	RLD, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N013263-004	VALIUM	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N013263-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N013263-004	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N013263-006	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N013263-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N013263-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N013263-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N013263-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N013263-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N013263-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N013263-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N013263-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N013263-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013263-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013263-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013263-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N013263-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N013263-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N013263-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013263-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013263-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013263-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013263-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013263-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013263-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N013263-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N013263-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N013263-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N013263-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N013263-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N013263-006	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N013263-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N013263-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N013263-006	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N013263-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N013263-004	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N013263-006	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N013263-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N013263-004	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N013263-006	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N013263-002	AB	1	`79d66fd596c7…`

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valium	DIAZEPAM	Roche Laboratories Inc.	554baee5-b171-4452-a50a-41a0946f956c	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 013263 application number: NDA013263 ndc (product): 0140-0004 ndc (product): 0140-0005

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 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0140-0004	Valium	diazepam	Roche Laboratories Inc.	NDA	Current
0140-0004	Valium	diazepam	Roche Laboratories Inc.	NDA	Current
0140-0004	Valium	diazepam	Roche Laboratories Inc.	NDA	Current
0140-0004	Valium	diazepam	Roche Laboratories Inc.	NDA	Current
0140-0004	Valium	diazepam	Roche Laboratories Inc.	NDA	Current
0140-0005	Valium	diazepam	Roche Laboratories Inc.	NDA	Current
0140-0005	Valium	diazepam	Roche Laboratories Inc.	NDA	Current
0140-0005	Valium	diazepam	Roche Laboratories Inc.	NDA	Current
0140-0005	Valium	diazepam	Roche Laboratories Inc.	NDA	Current
0140-0005	Valium	diazepam	Roche Laboratories Inc.	NDA	Current
0140-0006	Valium	diazepam	Roche Laboratories Inc.	NDA	Current
0140-0006	Valium	diazepam	Roche Laboratories Inc.	NDA	Current
0140-0006	Valium	diazepam	Roche Laboratories Inc.	NDA	Current
0140-0006	Valium	diazepam	Roche Laboratories Inc.	NDA	Current
0140-0006	Valium	diazepam	Roche Laboratories Inc.	NDA	Current
55289-117	Valium	diazepam	PD-Rx Pharmaceuticals, Inc.	NDA	Current
65084-312	Valium	diazepam	Mckesson Rxpak Inc	NDA	Current
65084-313	Valium	diazepam	Mckesson Rxpak Inc	NDA	Current
80725-004	Valium	Diazepam	Waylis Therapuetics LLC	NDA	Current
80725-004	Valium	Diazepam	Waylis Therapuetics LLC	NDA	Current
80725-005	Valium	Diazepam	Waylis Therapuetics LLC	NDA	Current
80725-005	Valium	Diazepam	Waylis Therapuetics LLC	NDA	Current
80725-006	Valium	Diazepam	Waylis Therapuetics LLC	NDA	Current
80725-006	Valium	Diazepam	Waylis Therapuetics LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78398	SUPPL	2024-05-06
78395	SUPPL	2024-05-06
75719	SUPPL	2023-10-13
75718	SUPPL	2023-10-13
75717	SUPPL	2023-10-12
75716	SUPPL	2023-10-12
73783	SUPPL	2023-03-17
73782	SUPPL	2023-03-17
73236	SUPPL	2023-01-17
73235	SUPPL	2023-01-17
73164	SUPPL	2023-01-17
66203	SUPPL	2021-02-12
66137	SUPPL	2021-02-09
46584	SUPPL	2016-12-29
46457	SUPPL	2016-12-22
46318	SUPPL	2016-12-20
33104	SUPPL	2013-10-25
12049	SUPPL	2013-10-24
10832	SUPPL	2008-06-05
12047	SUPPL	2008-05-14
358	SUPPL	2008-05-14
40690	SUPPL	2007-07-09
40688	SUPPL	2007-07-06
40687	SUPPL	2007-07-06
20044	SUPPL	2007-07-06
40689	SUPPL	2006-10-25
357	SUPPL	2004-06-29
359	SUPPL	2002-02-12
12046	SUPPL	2002-02-07
12048	SUPPL	2001-05-09