Application 071135

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	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
A071135-001	DIAZEPAM	DIAZEPAM	5MG	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
A071135-001	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	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071135-001	DIAZEPAM	5MG	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	A071135-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071135-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071135-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071135-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071135-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071135-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071135-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071135-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071135-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071135-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071135-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071135-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071135-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071135-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071135-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071135-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071135-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071135-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071135-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071135-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071135-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071135-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071135-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071135-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071135-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071135-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071135-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071135-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071135-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071135-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071135-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071135-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071135-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071135-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071135-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071135-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071135-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071135-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071135-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071135-001	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 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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 65 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-5880	Diazepam	Diazepam	Major Pharmaceuticals	ANDA	Current
0904-5880	Diazepam	Diazepam	Major Pharmaceuticals	ANDA	Current
35356-716	Diazepam	Diazepam	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	ANDA	Current
43063-887	Diazepam	Diazepam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-887	Diazepam	Diazepam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43353-278	Diazepam	Diazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
45865-482	Diazepam	Diazepam	Medsource Pharmaceuticals	ANDA	Current
50090-2995	Diazepam	Diazepam	A-S Medication Solutions	ANDA	Current
51862-063	Diazepam	Diazepam	Mayne Pharma	ANDA	Current
51862-063	Diazepam	Diazepam	Mayne Pharma	ANDA	Current
51862-063	Diazepam	Diazepam	Mayne Pharma	ANDA	Current
51862-063	Diazepam	Diazepam	Mayne Pharma	ANDA	Current
51862-063	Diazepam	Diazepam	Mayne Pharma	ANDA	Current
51862-942	Diazepam	Diazepam	Mayne Pharma	ANDA	Current
51862-942	Diazepam	Diazepam	Mayne Pharma	ANDA	Current
51862-942	Diazepam	Diazepam	Mayne Pharma	ANDA	Current
51862-942	Diazepam	Diazepam	Mayne Pharma	ANDA	Current
52959-047	DIAZEPAM	DIAZEPAM	H.J. Harkins Company, Inc.	ANDA	Current
55154-1492	Diazepam	Diazepam	Cardinal Health	ANDA	Current
55154-7885	Diazepam	Diazepam	Cardinal Health	ANDA	Current
55700-439	Diazepam	Diazepam	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
60760-934	Diazepam	Diazepam	St. Mary's Medical Park Pharmacy	ANDA	Current
61919-088	DIAZEPAM	DIAZEPAM	DIRECT RX	ANDA	Current
61919-088	DIAZEPAM	DIAZEPAM	Direct_Rx	ANDA	Current
61919-088	DIAZEPAM	DIAZEPAM	Direct_Rx	ANDA	Current
61919-088	DIAZEPAM	DIAZEPAM	Direct_Rx	ANDA	Current
61919-367	Diazepam	Diazepam	Direct Rx	ANDA	Current
63187-867	Diazepam	Diazepam	Proficient Rx LP	ANDA	Current
63187-867	Diazepam	Diazepam	Proficient Rx LP	ANDA	Current
63739-073	Diazepam	Diazepam	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-073	Diazepam	Diazepam	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-073	Diazepam	Diazepam	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-073	Diazepam	Diazepam	McKesson Corporation	ANDA	Current
66267-069	Diazepam	Diazepam	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-069	Diazepam	Diazepam	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-776	Diazepam	Diazepam	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-776	Diazepam	Diazepam	NuCare Pharmaceuticals, Inc.	ANDA	Current
67046-941	Diazepam	Diazepam	Contract Pharmacy Services-PA	ANDA	Current
67046-946	Diazepam	Diazepam	Contract Pharmacy Services-PA	ANDA	Current
67296-0506	Diazepam	diazepam	RedPharm Drug Inc.	ANDA	Current
67296-1349	Diazepam	Diazepam	RedPharm Drug, Inc.	ANDA	Current
67296-1349	Diazepam	Diazepam	RedPharm Drug, Inc.	ANDA	Current
67544-019	Diazepam	Diazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
68071-2826	Diazepam	Diazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2828	Diazepam	Diazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3270	Diazepam	Diazepam	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3270	Diazepam	Diazepam	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3330	Diazepam	Diazepam	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3330	Diazepam	Diazepam	NuCare Pharmaceuticals, Inc.	ANDA	Current
68788-6851	Diazepam	Diazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6851	Diazepam	Diazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6851	Diazepam	Diazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8281	Diazepam	Diazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
71335-0495	Diazepam	Diazepam	Bryant Ranch Prepack	ANDA	Current
71335-0495	Diazepam	Diazepam	Bryant Ranch Prepack	ANDA	Current
71335-0495	Diazepam	Diazepam	Bryant Ranch Prepack	ANDA	Current
71335-0495	Diazepam	Diazepam	Bryant Ranch Prepack	ANDA	Current
71335-1627	Diazepam	Diazepam	Bryant Ranch Prepack	ANDA	Current
71335-2197	Diazepam	Diazepam	Bryant Ranch Prepack	ANDA	Current
71610-459	Diazepam	Diazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-459	Diazepam	Diazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-459	Diazepam	Diazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-459	Diazepam	Diazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72189-401	Valium	Diazepam	Direct_Rx	ANDA	Current
72189-401	Valium	Diazepam	Direct_Rx	ANDA	Current