Application 071136

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	10MG	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
A071136-001	DIAZEPAM	DIAZEPAM	10MG	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
A071136-001	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	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071136-001	DIAZEPAM	10MG	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	A071136-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071136-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071136-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071136-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071136-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071136-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071136-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071136-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071136-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071136-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071136-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071136-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071136-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071136-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071136-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071136-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071136-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071136-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071136-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071136-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071136-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071136-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071136-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071136-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071136-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071136-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071136-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071136-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071136-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071136-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071136-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071136-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071136-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071136-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071136-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071136-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071136-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071136-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071136-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071136-001	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 1 of 5 · 89 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diazepam	DIAZEPAM	Cardinal Health 107, LLC	ba953b22-f0cd-4be5-9e0e-178bded88727	2026-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Civica, Inc.	cf7bd9ba-5030-479a-8448-3a99395b0d0c	2026-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Valium	DIAZEPAM	Waylis Therapuetics LLC	260e2041-2bb3-482f-850e-b5d47a7bdbe6	2026-08-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DIAZEPAM
Diazepam	DIAZEPAM	REMEDYREPACK INC.	c57af2a2-aa9a-4dac-a200-e0d845005d05	2026-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	REMEDYREPACK INC.	b4a045e4-d6ce-475d-abe4-590941bd3815	2026-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	REMEDYREPACK INC.	20e08b97-bb89-4129-a228-8ad9cf35a1d3	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Hikma Pharmaceuticals USA Inc.	f466f8a3-f31c-44f4-b0e8-444464f20f66	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	REMEDYREPACK INC.	5ebef149-1858-4199-aaed-7b9341fae63d	2026-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Unit Dose Solutions, Inc.	547c2ad4-113c-7771-e063-6394a90a2073	2026-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Valtoco	DIAZEPAM	Neurelis, Inc	1a8bcc90-68fa-474d-832c-0df01e825f39	2026-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DIAZEPAM
Diazepam	DIAZEPAM	Navinta LLC	b5b17a28-2cab-4c0d-8f9d-7b224e4d0989	2026-05-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Hospira, Inc.	7e7dd743-a87b-4ab3-b6ae-f116cd0c8b0f	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Coupler LLC	5111654f-a026-71b2-e063-6294a90ab49b	2026-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Coupler LLC	5114ae6e-8cae-e96f-e063-6294a90a9e60	2026-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Baxter Healthcare Corporation	a0813073-d0b0-4fd7-b307-56f69c910c82	2026-05-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Zydus Pharmaceuticals USA Inc.	652714c7-25c4-4d05-979d-8eee3b6f2f4d	2026-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Dr. Reddy's Laboratories Inc	2a633cef-6dfc-4186-b595-174db2d8330e	2026-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Dr. Reddy's Laboratories Inc	9a860a4e-d670-d050-499d-eb1fd6b16176	2026-04-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Preferred Pharmaceuticals Inc.	6dcbb5e9-1e8f-4069-9244-adb46356714d	2026-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Preferred Pharmaceuticals Inc.	7646785b-dabc-482d-bf42-06177f00aca2	2026-04-01	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 · 45 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
35356-724	Diazepam	Diazepam	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	ANDA	Current
43353-276	Diazepam	Diazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
45865-140	Diazepam	Diazepam	Medsource Pharmaceuticals	ANDA	Current
45865-423	Diazepam	Diazepam	Medsource Pharmaceuticals	ANDA	Current
51862-064	Diazepam	Diazepam	Mayne Pharma	ANDA	Current
51862-064	Diazepam	Diazepam	Mayne Pharma	ANDA	Current
51862-064	Diazepam	Diazepam	Mayne Pharma	ANDA	Current
51862-064	Diazepam	Diazepam	Mayne Pharma	ANDA	Current
51862-943	Diazepam	Diazepam	Mayne Pharma	ANDA	Current
51862-943	Diazepam	Diazepam	Mayne Pharma	ANDA	Current
51862-943	Diazepam	Diazepam	Mayne Pharma	ANDA	Current
51862-943	Diazepam	Diazepam	Mayne Pharma	ANDA	Current
52959-306	DIAZEPAM	DIAZEPAM	H.J. Harkins Company, Inc.	ANDA	Current
55700-442	Diazepam	Diazepam	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-442	Diazepam	Diazepam	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
58118-0640	Diazepam	Diazepam	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-0640	Diazepam	Diazepam	Clinical Solutions Wholesale, LLC	ANDA	Current
61919-131	DIAZEPAM	DIAZEPAM	DIRECT RX	ANDA	Current
61919-131	DIAZEPAM	DIAZEPAM	Direct_Rx	ANDA	Current
61919-131	DIAZEPAM	DIAZEPAM	Direct_Rx	ANDA	Current
61919-131	DIAZEPAM	DIAZEPAM	Direct_Rx	ANDA	Current
61919-131	DIAZEPAM	DIAZEPAM	Direct_Rx	ANDA	Current
61919-131	DIAZEPAM	DIAZEPAM	Direct_Rx	ANDA	Current
63187-846	Diazepam	Diazepam	Proficient Rx LP	ANDA	Current
63187-846	Diazepam	Diazepam	Proficient Rx LP	ANDA	Current
64725-5620	Diazepam	Diazepam	TYA Pharmaceuticals	ANDA	Current
67046-942	Diazepam	Diazepam	Contract Pharmacy Services-PA	ANDA	Current
67046-947	Diazepam	Diazepam	Contract Pharmacy Services-PA	ANDA	Current
67544-020	Diazepam	Diazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
68071-4030	Diazepam	Diazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4181	Diazepam	Diazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4181	Diazepam	Diazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-6942	Diazepam	Diazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
71335-0142	Diazepam	Diazepam	Bryant Ranch Prepack	ANDA	Current
71335-0142	Diazepam	Diazepam	Bryant Ranch Prepack	ANDA	Current
71335-2196	Diazepam	Diazepam	Bryant Ranch Prepack	ANDA	Current
71610-427	Diazepam	Diazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-427	Diazepam	Diazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-427	Diazepam	Diazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-427	Diazepam	Diazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72189-400	Valium	Diazepam	Direct_Rx	ANDA	Current
80425-0151	Valium	Diazepam 10mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0151	Diazepam	Diazepam	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0151	Diazepam	Diazepam	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0151	Diazepam	Diazepam	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current