Application 214992

Type: ANDA
Sponsor: DEXCEL PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VIGABATRIN	VIGABATRIN	FOR SOLUTION;ORAL	500MG/PACKET	No	No

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

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
A214992-001	VIGABATRIN	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL			2021-05-13

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.

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	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL		2021-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL		2021-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL	AA	2021-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL	AA	2021-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL	AA	2021-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL	AA	2021-05-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL	AA	2021-05-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL	AA	2021-05-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL	AA	2021-05-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL	AA	2021-05-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL	AA	2021-05-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL	AA	2021-05-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL	AA	2021-05-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL	AA	2021-05-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL	AA	2021-05-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL	AA	2021-05-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL	AA	2021-05-13	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL	AA	2021-05-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL	AA	2021-05-13	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL	AA	2021-05-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL	AA	2021-05-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL	AA	2021-05-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL	AA	2021-05-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL	AA	2021-05-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL	AA	2021-05-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL	AA	2021-05-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL	AA	2021-05-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL	AA	2021-05-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL	AA	2021-05-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL	AA	2021-05-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL	AA	2021-05-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL	AA	2021-05-13	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214992-001	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL		2021-05-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A214992-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214992-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214992-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214992-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214992-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214992-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214992-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214992-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214992-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214992-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214992-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214992-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214992-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214992-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214992-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214992-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214992-001	AA	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214992-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214992-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214992-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214992-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214992-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214992-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214992-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214992-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214992-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214992-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214992-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214992-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214992-001	AA	1	`cb3db0bc1861…`

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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VIGADRONE	VIGABATRIN	Upsher-Smith Laboratories, LLC	5e5e7554-d0f4-47f7-a434-cc5ca5a9826f	2026-06-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VIGABATRIN
Vigabatrin	VIGABATRIN	Novadoz Pharmaceuticals LLC	082d818a-4f4e-4675-98c6-91db0294e63c	2026-06-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Vigabatrin generic name: VIGABATRIN
vigabatrin	VIGABATRIN	Carnegie Pharmaceuticals LLC	8406bd5a-8887-4579-a11e-5ab449c58963	2026-02-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: vigabatrin generic name: VIGABATRIN
VIGABATRIN	VIGABATRIN	Par Health USA, LLC	e7cbc0a5-8c28-4451-9176-b608e228ba66	2026-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VIGABATRIN generic name: VIGABATRIN
vigabatrin	VIGABATRIN	Zydus Lifesciences Limited	cd5ebc7a-8d5b-46b4-ad9b-e4a25fa3e26c	2025-11-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: vigabatrin generic name: VIGABATRIN
vigabatrin	VIGABATRIN	Zydus Lifesciences Limited	e9c99000-fc0c-4083-b620-ba9ac821f8ac	2025-11-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: vigabatrin generic name: VIGABATRIN
VIGAFYDE	VIGABATRIN	Upsher-Smith Laboratories, LLC	8d3d6316-33ab-41e8-9485-4495c218be56	2025-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VIGABATRIN
Vigabatrin	VIGABATRIN	Aurobindo Pharma Limited	c97ce40c-1c5a-479d-9188-5ce03cf7e065	2025-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Vigabatrin generic name: VIGABATRIN
VIGADRONE	VIGABATRIN	Upsher-Smith Laboratories, LLC	01f7f049-78c2-47c2-a66e-ec662ba48a98	2024-11-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VIGABATRIN
Vigabatrin	VIGABATRIN	Actavis Pharma, Inc.	8dc7bd15-2636-4d58-b651-dd117ca43dbd	2024-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Vigabatrin generic name: VIGABATRIN
Vigabatrin	VIGABATRIN	Dr. Reddys Laboratories Inc.,	f6be436e-46c7-e9ab-0fcf-e8d04dc12b72	2024-06-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Vigabatrin generic name: VIGABATRIN
vigabatrin for oral solution	VIGABATRIN	Camber Pharmaceuticals, Inc.	bda491b6-47ba-400b-9816-b6d15c6e2683	2024-04-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VIGABATRIN
vigabatrin	VIGABATRIN	Zydus Pharmaceuticals (USA) Inc.	6d3fc853-1b2d-47ad-a4f2-f11505601bc2	2024-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: vigabatrin generic name: VIGABATRIN
vigabatrin	VIGABATRIN	Zydus Pharmaceuticals (USA) Inc.	6c0bf4fb-b234-4053-9163-1e8d0142d718	2024-03-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: vigabatrin generic name: VIGABATRIN
Vigabatrin	VIGABATRIN	Aurobindo Pharma Limited	4aaea88b-e0fd-45e3-bb02-604bf8ee9b5b	2024-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Vigabatrin generic name: VIGABATRIN
Vigabatrin	VIGABATRIN	Amneal Pharmaceuticals NY LLC	9791494f-492b-487a-8211-7747fb57923e	2023-02-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Vigabatrin generic name: VIGABATRIN
Vigabatrin	VIGABATRIN	Amneal Pharmaceuticals NY LLC	5b8fb137-848b-45fd-9107-a6db5a675360	2022-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Vigabatrin generic name: VIGABATRIN
Vigabatrin	VIGABATRIN	Amneal Pharmaceuticals NY LLC	04fef2ec-c275-405d-91b1-99a74ee8caa2	2022-11-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Vigabatrin generic name: VIGABATRIN
VIGABATRIN	VIGABATRIN	Ascend Laboratories, LLC	ee835fb6-2b2b-40c4-b6d7-0ad0e790cda8	2022-11-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VIGABATRIN generic name: VIGABATRIN
Vigabatrin	VIGABATRIN	Edenbridge Pharmaceuticals LLC.	93ba3894-fd97-4432-9f2d-e7050371e91f	2022-08-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Vigabatrin generic name: VIGABATRIN

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0574-0470	VIGABATRIN	vigabatrin	Padagis US LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76258	ORIG	2023-11-03