Application 217843

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIAZEPAM	DIAZEPAM	TABLET;ORAL	2MG	No	No
002	DIAZEPAM	DIAZEPAM	TABLET;ORAL	5MG	No	No
003	DIAZEPAM	DIAZEPAM	TABLET;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	Approval date
A217843-001	DIAZEPAM	DIAZEPAM	2MG	TABLET / ORAL	AB	2023-12-14
A217843-002	DIAZEPAM	DIAZEPAM	5MG	TABLET / ORAL	AB	2023-12-14
A217843-003	DIAZEPAM	DIAZEPAM	10MG	TABLET / ORAL	AB	2023-12-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217843-001	AB
A217843-002	AB
A217843-003	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 · 51 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
2026-02-19 14:30 UTC	2026-02	A217843-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217843-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217843-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2023-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217843-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2023-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217843-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2023-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217843-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2023-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217843-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2023-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217843-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2023-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217843-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2023-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217843-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2023-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217843-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2023-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217843-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2023-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217843-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2023-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217843-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2023-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217843-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2023-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217843-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2023-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217843-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2023-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217843-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2023-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217843-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2023-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217843-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2023-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217843-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2023-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217843-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2023-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217843-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2023-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217843-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2023-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217843-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2023-12-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217843-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2023-12-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217843-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2023-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217843-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2023-12-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217843-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2023-12-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217843-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2023-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217843-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2023-12-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217843-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2023-12-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217843-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2023-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217843-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2023-12-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217843-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2023-12-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217843-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2023-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217843-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2023-12-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217843-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2023-12-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217843-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2023-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217843-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2023-12-14	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 51 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A217843-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217843-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217843-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217843-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217843-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217843-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217843-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217843-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217843-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217843-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217843-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217843-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217843-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217843-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217843-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217843-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217843-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217843-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217843-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217843-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217843-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217843-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217843-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217843-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217843-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217843-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217843-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217843-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217843-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217843-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217843-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217843-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217843-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217843-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217843-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217843-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217843-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217843-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217843-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217843-001	AB	1	`8072bd15b7f6…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DIAZEPAM	DIAZEPAM	ASCLEMED USA INC.	426f3da1-4105-ba0a-e063-6294a90a7a86	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217843 application number: ANDA217843
DIAZEPAM	DIAZEPAM	Advanced Rx of Tennessee, LLC	32c3af91-a57a-1278-e063-6294a90ae5ec	2025-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217843 application number: ANDA217843
DIAZEPAM	DIAZEPAM	Proficient Rx LP	9322b0bc-e9fa-4c89-808b-110decf6db58	2025-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217843 application number: ANDA217843
DIAZEPAM	DIAZEPAM	NuCare Pharmaceuticals, Inc.	21785bb2-cc96-7973-e063-6294a90ab1b8	2024-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217843 application number: ANDA217843
DIAZEPAM	DIAZEPAM	NuCare Pharmaceuticals, Inc	22688087-27ad-620c-e063-6394a90a134c	2024-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217843 application number: ANDA217843
DIAZEPAM	DIAZEPAM	Aurobindo Pharma Limited	2f799120-0d08-47cd-8183-a98f0267c845	2023-12-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217843 application number: ANDA217843