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 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 · 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