Application 205467

Type: ANDA
Sponsor: SUN PHARM

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 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
A205467-001	FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET / ORAL	AB		2019-07-01
A205467-002	FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET / ORAL	AB		2019-07-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205467-001	AB
A205467-002	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	A205467-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205467-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205467-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205467-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205467-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205467-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205467-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205467-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205467-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205467-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205467-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205467-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205467-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205467-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205467-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205467-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205467-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205467-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205467-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205467-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205467-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205467-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205467-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205467-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205467-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205467-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205467-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205467-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205467-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205467-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205467-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205467-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205467-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205467-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205467-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205467-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205467-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205467-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205467-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205467-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`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	A205467-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205467-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205467-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205467-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205467-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205467-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205467-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205467-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205467-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205467-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205467-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205467-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205467-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205467-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205467-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205467-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205467-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205467-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205467-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205467-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205467-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205467-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205467-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205467-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205467-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205467-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205467-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205467-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205467-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205467-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205467-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205467-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205467-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205467-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205467-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205467-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205467-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205467-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205467-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205467-002	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Febuxostat	FEBUXOSTAT	NuCare Pharmaceuticals, Inc.	2b5cf14a-6c5f-1eb2-e063-6294a90aaac8	2025-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205467 application number: ANDA205467
Febuxostat	FEBUXOSTAT	American Health Packaging	14f80ad5-37cc-4672-9caa-2dd2f469af0a	2024-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205467 application number: ANDA205467 ndc (product): 60687-538
Febuxostat	FEBUXOSTAT	NorthStar RxLLC	ad40e0f6-850c-429a-87fc-f1eb2361e962	2023-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205467 application number: ANDA205467 ndc (product): 16714-059 ndc (product): 16714-060
Febuxostat	FEBUXOSTAT	Sun Pharmaceutical Industries, Inc.	1f7541bd-bf32-422b-b99a-89193cf193ca	2023-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205467 application number: ANDA205467 ndc (product): 47335-722 ndc (product): 47335-721

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-059	Febuxostat	Febuxostat	NorthStar RxLLC	ANDA	Current
16714-060	Febuxostat	Febuxostat	NorthStar RxLLC	ANDA	Current
47335-721	Febuxostat	Febuxostat	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-722	Febuxostat	Febuxostat	Sun Pharmaceutical Industries, Inc.	ANDA	Current
60687-538	Febuxostat	Febuxostat	American Health Packaging	ANDA	Current