Application 208970

Type: ANDA
Sponsor: CADILA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FELBAMATE	FELBAMATE	TABLET;ORAL	400MG	No	No
002	FELBAMATE	FELBAMATE	TABLET;ORAL	600MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208970-001	FELBAMATE	FELBAMATE	400MG	TABLET / ORAL	AB		2017-05-30
A208970-002	FELBAMATE	FELBAMATE	600MG	TABLET / ORAL	AB		2017-05-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A208970-001	AB
A208970-002	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 3 · 84 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
2026-08-18 06:07:40	2026-07	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A208970-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208970-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208970-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208970-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208970-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208970-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208970-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208970-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208970-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208970-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208970-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208970-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208970-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208970-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208970-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208970-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208970-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208970-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208970-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208970-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208970-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208970-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208970-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208970-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208970-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208970-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208970-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208970-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208970-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208970-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208970-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208970-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208970-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208970-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208970-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208970-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208970-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208970-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208970-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208970-002	AB	1	`bb7c543d1eb4…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Felbamate	FELBAMATE	Viona Pharmaceuticals Inc	96f4357c-720c-4651-b638-7b1181531dc5	2026-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208970 application number: ANDA208970 ndc (product): 72578-057 ndc (product): 72578-056
Felbamate	FELBAMATE	Zydus Lifesciences Limited	efa55cb2-b625-4392-9ddb-0a8ad8ee58c4	2024-08-16		Exact identifier application applno (ANDA): 208970 application number: ANDA208970 ndc (product): 70771-1078 ndc (product): 70771-1077

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70710-1053	Felbamate	Felbamate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1053	Felbamate	Felbamate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1054	Felbamate	Felbamate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1054	Felbamate	Felbamate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1077	Felbamate	Felbamate	Cadila Healthcare Limited	ANDA	Current
70771-1077	Felbamate	Felbamate	Zydus Lifesciences Limited	ANDA	Current
70771-1077	Felbamate	Felbamate	Cadila Healthcare Limited	ANDA	Current
70771-1077	Felbamate	Felbamate	Cadila Healthcare Limited	ANDA	Current
70771-1078	Felbamate	Felbamate	Cadila Healthcare Limited	ANDA	Current
70771-1078	Felbamate	Felbamate	Zydus Lifesciences Limited	ANDA	Current
70771-1078	Felbamate	Felbamate	Cadila Healthcare Limited	ANDA	Current
70771-1078	Felbamate	Felbamate	Cadila Healthcare Limited	ANDA	Current
72578-056	Felbamate	Felbamate	Viona Pharmaceuticals Inc	ANDA	Current
72578-056	Felbamate	Felbamate	Viona Pharmaceuticals Inc	ANDA	Current
72578-057	Felbamate	Felbamate	Viona Pharmaceuticals Inc	ANDA	Current
72578-057	Felbamate	Felbamate	Viona Pharmaceuticals Inc	ANDA	Current