Application 205385

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FEBUXOSTAT	FEBUXOSTAT	TABLET;ORAL	40MG	No	No
002	FEBUXOSTAT	FEBUXOSTAT	TABLET;ORAL	80MG	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
A205385-001	FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET / ORAL			2019-07-01
A205385-002	FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET / ORAL			2019-07-01

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	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205385-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205385-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205385-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205385-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205385-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205385-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205385-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205385-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205385-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205385-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205385-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205385-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205385-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205385-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205385-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A205385-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205385-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205385-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205385-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205385-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205385-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205385-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205385-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205385-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205385-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205385-002	AB	1	`ea99ee380514…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205385-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205385-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205385-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205385-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205385-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A205385-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205385-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A205385-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205385-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205385-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205385-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A205385-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205385-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A205385-002	AB	1	`e64feba35796…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A205385-001	PC	2019-12-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205385-002	PC	2019-12-28	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A205385-001	PC	2019-12-28	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205385-002	PC	2019-12-28	`3f01610625f2…`

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 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
febuxostat	FEBUXOSTAT	REMEDYREPACK INC.	f2c338dc-5bab-49f4-a4ac-d8dea8afeea5	2026-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: febuxostat generic name: FEBUXOSTAT
FEBUXOSTAT	FEBUXOSTAT	HEC Pharm USA Inc.	4f1d0452-e041-cda6-e063-6394a90a2aef	2026-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: FEBUXOSTAT generic name: FEBUXOSTAT
Febuxostat	FEBUXOSTAT	Novadoz Pharmaceuticals LLC	d1969ea8-5178-42ee-97fc-feee8595e677	2026-02-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Febuxostat generic name: FEBUXOSTAT
ULORIC	FEBUXOSTAT	Takeda Pharmaceuticals America, Inc.	54de10ef-fe5f-4930-b91d-6bbb04c664bd	2025-12-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FEBUXOSTAT
Febuxostat	FEBUXOSTAT	Major Pharmaceuticals	164feabd-f722-445b-b81a-d975b3db5f53	2025-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Febuxostat generic name: FEBUXOSTAT
Febuxostat	FEBUXOSTAT	NuCare Pharmaceuticals, Inc.	2b5cf14a-6c5f-1eb2-e063-6294a90aaac8	2025-01-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Febuxostat generic name: FEBUXOSTAT
febuxostat	FEBUXOSTAT	NuCare Pharmaceuticals, Inc.	2b5d205f-30e3-33e6-e063-6394a90aa683	2025-01-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: febuxostat generic name: FEBUXOSTAT
febuxostat	FEBUXOSTAT	Zydus Lifesciences Limited	0629ab39-196e-4198-902a-3c16277ba205	2024-08-16		Name fallback brand name: febuxostat generic name: FEBUXOSTAT
Febuxostat	FEBUXOSTAT	NuCare Pharmaceuticals,Inc.	a745be75-4fa5-cbf9-e053-2995a90a3a81	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Febuxostat generic name: FEBUXOSTAT
Febuxostat	FEBUXOSTAT	MAJOR PHARMACEUTICALS	13a80059-46f7-4453-ab37-72744657a08a	2024-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Febuxostat generic name: FEBUXOSTAT
Febuxostat	FEBUXOSTAT	Aurobindo Pharma Limited	04f80eb2-8171-4e18-93e4-514440e84b75	2024-05-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Febuxostat generic name: FEBUXOSTAT
Febuxostat	FEBUXOSTAT	Golden State Medical Supply, Inc.	97a8c7fc-0a66-2ddc-e053-2a95a90ad313	2024-04-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Febuxostat generic name: FEBUXOSTAT
Febuxostat	FEBUXOSTAT	American Health Packaging	14f80ad5-37cc-4672-9caa-2dd2f469af0a	2024-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Febuxostat generic name: FEBUXOSTAT
FEBUXOSTAT	FEBUXOSTAT	Lannett Company, Inc.	73b07a94-c044-42dc-abe4-7d7c860c9638	2024-01-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: FEBUXOSTAT generic name: FEBUXOSTAT
Febuxostat	FEBUXOSTAT	NorthStar RxLLC	ad40e0f6-850c-429a-87fc-f1eb2361e962	2023-11-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Febuxostat generic name: FEBUXOSTAT
Febuxostat	FEBUXOSTAT	Sun Pharmaceutical Industries, Inc.	1f7541bd-bf32-422b-b99a-89193cf193ca	2023-11-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Febuxostat generic name: FEBUXOSTAT
Febuxostat	FEBUXOSTAT TABLETS 40 MG	Macleods Pharmaceuticals Limited	77875ed1-049e-421b-a8d5-569b4af4a1b5	2023-09-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Febuxostat
Febuxostat	FEBUXOSTAT	Tris Pharma Inc	d3b18653-9487-4a78-82c0-80ee024b8ef6	2023-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Febuxostat generic name: FEBUXOSTAT
FEBUXOSTAT	FEBUXOSTAT	Solco Healthcare US LLC	4f5f8f2b-7200-4d76-9049-11dbc6cbd2ca	2023-06-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: FEBUXOSTAT generic name: FEBUXOSTAT
Febuxostat	FEBUXOSTAT	Hikma Pharmaceuticals USA Inc	14f1555c-2565-42c7-b3f5-dd5f03fed67a	2023-05-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Febuxostat generic name: FEBUXOSTAT

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-3925	Febuxostat	febuxostat	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3926	Febuxostat	febuxostat	Mylan Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
59592	ORIG	2019-08-06