Application 204595

Type: ANDA
Sponsor: ALVOGEN

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
A204595-001	FELBAMATE	FELBAMATE	400MG	TABLET / ORAL			2016-01-11
A204595-002	FELBAMATE	FELBAMATE	600MG	TABLET / ORAL			2016-01-11

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	A204595-001	FELBAMATE	400MG	TABLET / ORAL		2016-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204595-002	FELBAMATE	600MG	TABLET / ORAL		2016-01-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204595-001	FELBAMATE	400MG	TABLET / ORAL		2016-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204595-002	FELBAMATE	600MG	TABLET / ORAL		2016-01-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204595-001	FELBAMATE	400MG	TABLET / ORAL		2016-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204595-002	FELBAMATE	600MG	TABLET / ORAL		2016-01-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204595-001	FELBAMATE	400MG	TABLET / ORAL	AB	2016-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204595-002	FELBAMATE	600MG	TABLET / ORAL	AB	2016-01-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204595-001	FELBAMATE	400MG	TABLET / ORAL	AB	2016-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204595-002	FELBAMATE	600MG	TABLET / ORAL	AB	2016-01-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204595-001	FELBAMATE	400MG	TABLET / ORAL	AB	2016-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204595-002	FELBAMATE	600MG	TABLET / ORAL	AB	2016-01-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204595-001	FELBAMATE	400MG	TABLET / ORAL	AB	2016-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204595-002	FELBAMATE	600MG	TABLET / ORAL	AB	2016-01-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204595-001	FELBAMATE	400MG	TABLET / ORAL	AB	2016-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204595-002	FELBAMATE	600MG	TABLET / ORAL	AB	2016-01-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204595-001	FELBAMATE	400MG	TABLET / ORAL	AB	2016-01-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204595-002	FELBAMATE	600MG	TABLET / ORAL	AB	2016-01-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204595-001	FELBAMATE	400MG	TABLET / ORAL	AB	2016-01-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204595-002	FELBAMATE	600MG	TABLET / ORAL	AB	2016-01-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204595-001	FELBAMATE	400MG	TABLET / ORAL	AB	2016-01-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204595-002	FELBAMATE	600MG	TABLET / ORAL	AB	2016-01-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204595-001	FELBAMATE	400MG	TABLET / ORAL	AB	2016-01-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204595-002	FELBAMATE	600MG	TABLET / ORAL	AB	2016-01-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204595-001	FELBAMATE	400MG	TABLET / ORAL	AB	2016-01-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204595-002	FELBAMATE	600MG	TABLET / ORAL	AB	2016-01-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204595-001	FELBAMATE	400MG	TABLET / ORAL	AB	2016-01-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204595-002	FELBAMATE	600MG	TABLET / ORAL	AB	2016-01-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204595-001	FELBAMATE	400MG	TABLET / ORAL	AB	2016-01-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204595-002	FELBAMATE	600MG	TABLET / ORAL	AB	2016-01-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204595-001	FELBAMATE	400MG	TABLET / ORAL	AB	2016-01-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204595-002	FELBAMATE	600MG	TABLET / ORAL	AB	2016-01-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204595-001	FELBAMATE	400MG	TABLET / ORAL	AB	2016-01-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204595-002	FELBAMATE	600MG	TABLET / ORAL	AB	2016-01-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204595-001	FELBAMATE	400MG	TABLET / ORAL	AB	2016-01-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204595-002	FELBAMATE	600MG	TABLET / ORAL	AB	2016-01-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204595-001	FELBAMATE	400MG	TABLET / ORAL	AB	2016-01-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204595-002	FELBAMATE	600MG	TABLET / ORAL	AB	2016-01-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204595-001	FELBAMATE	400MG	TABLET / ORAL	AB	2016-01-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204595-002	FELBAMATE	600MG	TABLET / ORAL	AB	2016-01-11	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204595-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204595-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204595-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204595-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204595-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204595-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204595-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204595-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204595-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204595-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204595-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204595-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204595-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204595-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204595-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204595-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204595-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204595-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204595-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204595-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204595-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204595-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204595-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204595-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204595-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204595-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204595-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204595-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204595-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204595-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204595-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204595-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204595-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204595-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204595-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204595-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204595-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204595-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204595-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A204595-002	AB	1	`8869cabd3fbd…`

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Felbamate	FELBAMATE	Sun Pharmaceutical Industries, Inc.	0afffb17-e6ac-4bea-a90e-7ef3c8150290	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Felbamate generic name: FELBAMATE
Felbamate	FELBAMATE	Sun Pharmaceutical Industries, Inc.	f2edb3ed-da20-4093-88ea-00fe781e47e0	2026-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Felbamate generic name: FELBAMATE
Felbamate	FELBAMATE	Amneal Pharmaceuticals of New York LLC	1aa40de5-c02d-49d6-8722-ed88c40c3ba6	2026-04-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Felbamate generic name: FELBAMATE
Felbamate	FELBAMATE	Bryant Ranch Prepack	6afd77f2-4525-42f4-a4b1-94159c401dd2	2026-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Felbamate generic name: FELBAMATE
Felbamate	FELBAMATE	Bryant Ranch Prepack	d6eaf094-09e2-480c-bea9-7a2768aad884	2026-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Felbamate generic name: FELBAMATE
Felbamate	FELBAMATE	Bryant Ranch Prepack	696e3cbb-a431-4f29-acbd-1db8e9aaef93	2026-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Felbamate generic name: FELBAMATE
Felbamate	FELBAMATE	Viona Pharmaceuticals Inc	96f4357c-720c-4651-b638-7b1181531dc5	2026-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Felbamate generic name: FELBAMATE
Felbamate	FELBAMATE	ANI Pharmaceuticals, Inc.	17850520-f823-4d05-8f9b-5eadfa68bae2	2025-11-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Felbamate generic name: FELBAMATE
Felbatol	FELBAMATE	Viatris Specialty LLC	2f522701-397a-11de-8a39-0800200c9a66	2025-08-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FELBAMATE
Felbamate	FELBAMATE	Bryant Ranch Prepack	3170233c-0452-4150-9e4c-dfffcde7424e	2025-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Felbamate generic name: FELBAMATE
Felbamate	FELBAMATE	Amneal Pharmaceuticals LLC	2e325d79-d0a4-4af7-b09b-96ee5a5b2a37	2024-10-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Felbamate generic name: FELBAMATE
Felbamate	FELBAMATE	Amneal Pharmaceuticals LLC	aa3fd2c0-98d6-45f3-81b0-a902526214c6	2024-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Felbamate generic name: FELBAMATE
Felbamate	FELBAMATE	Zydus Lifesciences Limited	efa55cb2-b625-4392-9ddb-0a8ad8ee58c4	2024-08-16		Name fallback brand name: Felbamate generic name: FELBAMATE
Felbamate	FELBAMATE	Novitium Pharma LLC	81c8a2e1-732c-4467-84e9-53fef1655ee2	2022-09-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Felbamate generic name: FELBAMATE
Felbamate	FELBAMATE	NORTHSTAR RX LLC	556de35d-3b98-48d3-a670-50e9d93437a4	2018-04-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Felbamate generic name: FELBAMATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47781-550	Felbamate	felbamate	Alvogen Inc.	ANDA	Current
47781-550	Felbamate	felbamate	Alvogen Inc.	ANDA	Current
47781-551	Felbamate	felbamate	Alvogen Inc.	ANDA	Current
47781-551	Felbamate	felbamate	Alvogen Inc.	ANDA	Current
47781-627	Felbamate	felbamate	Alvogen Inc.	ANDA	Current
47781-627	Felbamate	felbamate	Alvogen Inc.	ANDA	Current
47781-627	Felbamate	felbamate	Alvogen Inc.	ANDA	Current
47781-627	Felbamate	felbamate	Alvogen Inc.	ANDA	Current
47781-630	Felbamate	felbamate	Alvogen Inc.	ANDA	Current
47781-630	Felbamate	felbamate	Alvogen Inc.	ANDA	Current
47781-630	Felbamate	felbamate	Alvogen Inc.	ANDA	Current
47781-630	Felbamate	felbamate	Alvogen Inc.	ANDA	Current