Application 202284

Type: ANDA
Sponsor: ANI PHARMS INC

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 1.

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
A202284-001	FELBAMATE	FELBAMATE	400MG	TABLET / ORAL	AB		2015-11-04
A202284-002	FELBAMATE	FELBAMATE	600MG	TABLET / ORAL	AB		2015-11-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202284-001	AB
A202284-002	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 · 82 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	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A202284-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202284-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202284-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202284-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202284-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202284-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202284-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202284-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202284-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202284-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202284-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202284-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202284-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202284-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202284-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202284-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202284-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202284-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202284-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202284-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202284-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202284-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202284-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202284-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202284-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202284-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202284-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202284-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202284-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202284-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202284-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202284-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202284-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202284-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202284-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202284-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202284-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202284-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202284-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202284-002	AB	1	`782e0a99824c…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Felbamate	FELBAMATE	Bryant Ranch Prepack	6afd77f2-4525-42f4-a4b1-94159c401dd2	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202284 application number: ANDA202284 ndc (product): 63629-1937
Felbamate	FELBAMATE	Bryant Ranch Prepack	d6eaf094-09e2-480c-bea9-7a2768aad884	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202284 application number: ANDA202284
Felbamate	FELBAMATE	Bryant Ranch Prepack	696e3cbb-a431-4f29-acbd-1db8e9aaef93	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202284 application number: ANDA202284
Felbamate	FELBAMATE	ANI Pharmaceuticals, Inc.	17850520-f823-4d05-8f9b-5eadfa68bae2	2025-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202284 application number: ANDA202284 ndc (product): 62559-731 ndc (product): 62559-730
Felbamate	FELBAMATE	Bryant Ranch Prepack	3170233c-0452-4150-9e4c-dfffcde7424e	2025-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202284 application number: ANDA202284 ndc (product): 63629-1944

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
0115-1746	Felbamate	Felbamate	Impax Generics	ANDA	Current
0115-1747	Felbamate	Felbamate	Impax Generics	ANDA	Current
62559-730	Felbamate	Felbamate	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-730	Felbamate	Felbamate	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-730	Felbamate	Felbamate	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-731	Felbamate	Felbamate	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-731	Felbamate	Felbamate	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-731	Felbamate	Felbamate	ANI Pharmaceuticals, Inc.	ANDA	Current
63629-1937	Felbamate	Felbamate	Bryant Ranch Prepack	ANDA	Current
63629-1937	Felbamate	Felbamate	Bryant Ranch Prepack	ANDA	Current
63629-1944	Felbamate	Felbamate	Bryant Ranch Prepack	ANDA	Current
63629-1944	Felbamate	Felbamate	Bryant Ranch Prepack	ANDA	Current
64720-256	Felbamate	Felbamate	CorePharma, LLC	ANDA	Current