Application 210363

Type: ANDA
Sponsor: BELOTECA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIAZEPAM	DIAZEPAM	INJECTABLE;INJECTION	10MG/2ML (5MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A210363-001	DIAZEPAM	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210363-001	AP

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		2019-03-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION		RS	2019-03-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION		RS	2019-03-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION		RS	2019-03-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION		RS	2019-03-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		2019-03-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		2019-03-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		2019-03-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A210363-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210363-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210363-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210363-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210363-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210363-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210363-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210363-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210363-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210363-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210363-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210363-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210363-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210363-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210363-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210363-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210363-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210363-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210363-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210363-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210363-001	AP	1	`782e0a99824c…`
2019-12-14 00:12 UTC	2019-12	A210363-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210363-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210363-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210363-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210363-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210363-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210363-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210363-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210363-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210363-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210363-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210363-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210363-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210363-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210363-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210363-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210363-001	AP	1	`a50c72e98297…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diazepam	DIAZEPAM	REMEDYREPACK INC.	c57af2a2-aa9a-4dac-a200-e0d845005d05	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210363 application number: ANDA210363 ndc (product): 70518-2358
Diazepam	DIAZEPAM	Natco Pharma USA LLC	6b8dc373-fa01-42c9-89af-4e00bf00180a	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210363 application number: ANDA210363 ndc (product): 69339-136
Diazepam	DIAZEPAM	Natco Pharma USA LLC	a14f5930-a3ac-4996-9778-df5baa3d0bab	2025-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210363 application number: ANDA210363 ndc (product): 69339-136
Diazepam	DIAZEPAM	Civica, Inc.	83646a0f-eb43-4871-b95e-683c2533d2be	2025-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210363 application number: ANDA210363 ndc (product): 72572-140

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69339-136	Diazepam	DIAZEPAM	Dash Pharmaceuticals LLC	ANDA	Current
69339-136	Diazepam	DIAZEPAM	Dash Pharmaceuticals LLC	ANDA	Current
69339-136	Diazepam	DIAZEPAM	Dash Pharmaceuticals LLC	ANDA	Current
69339-136	Diazepam	DIAZEPAM	Dash Pharmaceuticals LLC	ANDA	Current
70518-2358	Diazepam	DIAZEPAM	REMEDYREPACK INC.	ANDA	Current
70518-2358	Diazepam	DIAZEPAM	REMEDYREPACK INC.	ANDA	Current
70518-2358	Diazepam	DIAZEPAM	REMEDYREPACK INC.	ANDA	Current
70518-2358	Diazepam	DIAZEPAM	REMEDYREPACK INC.	ANDA	Current
70518-2358	Diazepam	DIAZEPAM	REMEDYREPACK INC.	ANDA	Current
72572-140	Diazepam	DIAZEPAM	Civica, Inc.	ANDA	Current
72572-140	Diazepam	DIAZEPAM	Civica, Inc.	ANDA	Current
72572-140	Diazepam	DIAZEPAM	Civica, Inc.	ANDA	Current
72572-140	Diazepam	DIAZEPAM	Civica, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73487	SUPPL	2023-02-13