Application 071134

Type: ANDA
Sponsor: MAYNE PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIAZEPAM	DIAZEPAM	TABLET;ORAL	2MG	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
A071134-001	DIAZEPAM	DIAZEPAM	2MG	TABLET / ORAL	AB		1987-02-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071134-001	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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071134-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1987-02-03	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A071134-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071134-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071134-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071134-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071134-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071134-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071134-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071134-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071134-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071134-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071134-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071134-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071134-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071134-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071134-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071134-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071134-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071134-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071134-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071134-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071134-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071134-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071134-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071134-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071134-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071134-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071134-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071134-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071134-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071134-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071134-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071134-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071134-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071134-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071134-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071134-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071134-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071134-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071134-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071134-001	AB	1	`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 2 of 5 · 89 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DIAZEPAM	DIAZEPAM	Henry Schein, Inc.	52fc91f4-992f-47cb-a7d2-b26d74577481	2026-03-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DIAZEPAM generic name: DIAZEPAM
Diazepam	DIAZEPAM	REMEDYREPACK INC.	d7a4b3c7-7021-4764-8c21-49e4bc6f6058	2026-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Safecor Health, LLC	8b51f4b3-a5e8-4400-b624-ac0c47630c86	2026-02-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Henry Schein, Inc.	bfa85a63-967f-4176-a752-0bafabbaaae3	2026-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Natco Pharma USA LLC	6b8dc373-fa01-42c9-89af-4e00bf00180a	2026-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Sagent Pharmaceuticals	7a912f1a-deee-46df-a8df-22a0afb06529	2026-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Direct_Rx	181cc7ac-5129-2200-e063-6394a90afd3a	2026-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
DIAZEPAM	DIAZEPAM	Direct_Rx	4b0c9c0a-4274-4d56-a7a4-bc497916469c	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: DIAZEPAM generic name: DIAZEPAM
Diazepam	DIAZEPAM	Lupin Pharmaceuticals,Inc.	d99b68aa-b3dc-49c8-8894-3da255cd26b0	2025-12-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM ORAL	Chartwell RX, LLC	cdb839fb-27e5-4a11-aed6-da0a7ab6e996	2025-12-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam
Valium	DIAZEPAM	Roche Laboratories Inc.	554baee5-b171-4452-a50a-41a0946f956c	2025-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DIAZEPAM
DIAZEPAM	DIAZEPAM	Henry Schein, Inc.	dcf7bc20-6c57-491a-b9e3-f42bacff8b99	2025-11-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DIAZEPAM generic name: DIAZEPAM
Diazepam	DIAZEPAM ORAL	Chartwell Governmental & Specialty RX, LLC.	167ee280-be68-4a28-a7d8-de41df14bc48	2025-11-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam
DIAZEPAM	DIAZEPAM	ASCLEMED USA INC.	426f3da1-4105-ba0a-e063-6294a90a7a86	2025-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DIAZEPAM generic name: DIAZEPAM
Diazepam	DIAZEPAM	A-S Medication Solutions	01f04ee4-fff9-499a-8213-984e16368084	2025-10-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	PD-Rx Pharmaceuticals, Inc.	c2768add-5e01-4ff4-afa3-230380d59a1f	2025-10-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	PD-Rx Pharmaceuticals, Inc.	1ad84940-40f7-457a-8ffa-53e1a7bfee16	2025-10-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	PD-Rx Pharmaceuticals, Inc.	2483426d-3782-432a-8b8d-86c06ef0de4a	2025-10-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	PD-Rx Pharmaceuticals, Inc.	84cecab3-d0e6-436b-996b-0b598e972308	2025-10-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Natco Pharma USA LLC	19d0e3e5-f081-4574-9f0a-e7e97a88c7a9	2025-09-08	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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43063-751	Diazepam	Diazepam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-751	Diazepam	Diazepam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43353-281	Diazepam	Diazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
51862-062	Diazepam	Diazepam	Mayne Pharma	ANDA	Current
51862-062	Diazepam	Diazepam	Mayne Pharma	ANDA	Current
51862-062	Diazepam	Diazepam	Mayne Pharma	ANDA	Current
51862-062	Diazepam	Diazepam	Mayne Pharma	ANDA	Current
51862-062	Diazepam	Diazepam	Mayne Pharma	ANDA	Current
51862-941	Diazepam	Diazepam	Mayne Pharma	ANDA	Current
51862-941	Diazepam	Diazepam	Mayne Pharma	ANDA	Current
51862-941	Diazepam	Diazepam	Mayne Pharma	ANDA	Current
51862-941	Diazepam	Diazepam	Mayne Pharma	ANDA	Current
52959-295	DIAZEPAM	DIAZEPAM	H.J. Harkins Company, Inc.	ANDA	Current
66336-579	Diazepam	Diazepam	Dispensing Solutions, Inc.	ANDA	Current
71335-0616	Diazepam	Diazepam	Bryant Ranch Prepack	ANDA	Current
71335-0616	Diazepam	Diazepam	Bryant Ranch Prepack	ANDA	Current
71335-0616	Diazepam	Diazepam	Bryant Ranch Prepack	ANDA	Current
71335-0616	Diazepam	Diazepam	Bryant Ranch Prepack	ANDA	Current
71335-2198	Diazepam	Diazepam	Bryant Ranch Prepack	ANDA	Current
71610-460	Diazepam	Diazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current