Application 213069

Type: ANDA
Sponsor: SUNSHINE LAKE

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
A213069-001	FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET / ORAL	AB		2020-06-02
A213069-002	FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET / ORAL	AB		2020-06-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213069-001	AB
A213069-002	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 2 · 74 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	A213069-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2020-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213069-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2020-06-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213069-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2020-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213069-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2020-06-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213069-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2020-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213069-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2020-06-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213069-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2020-06-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213069-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2020-06-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213069-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2020-06-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213069-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2020-06-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213069-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2020-06-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213069-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2020-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213069-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2020-06-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213069-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2020-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213069-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2020-06-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213069-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2020-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213069-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2020-06-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213069-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2020-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213069-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2020-06-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213069-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2020-06-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213069-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2020-06-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213069-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2020-06-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213069-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2020-06-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213069-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2020-06-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213069-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2020-06-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213069-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2020-06-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213069-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2020-06-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213069-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2020-06-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213069-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2020-06-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213069-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2020-06-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213069-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2020-06-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213069-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2020-06-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213069-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2020-06-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213069-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2020-06-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213069-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2020-06-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213069-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2020-06-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213069-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2020-06-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213069-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2020-06-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213069-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2020-06-02	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213069-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2020-06-02	`87673890dc5c…`

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
2026-02-19 14:30 UTC	2026-02	A213069-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213069-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213069-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213069-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213069-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213069-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213069-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213069-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213069-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213069-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213069-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213069-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213069-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213069-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213069-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213069-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213069-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213069-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213069-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213069-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213069-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213069-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213069-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213069-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213069-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213069-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213069-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213069-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213069-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213069-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213069-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213069-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213069-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213069-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213069-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213069-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213069-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213069-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213069-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213069-002	AB	1	`87673890dc5c…`

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
FEBUXOSTAT	FEBUXOSTAT	HEC Pharm USA Inc.	4f1d0452-e041-cda6-e063-6394a90a2aef	2026-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213069 application number: ANDA213069
FEBUXOSTAT	FEBUXOSTAT	Lannett Company, Inc.	73b07a94-c044-42dc-abe4-7d7c860c9638	2024-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213069 application number: ANDA213069 ndc (product): 0527-2248 ndc (product): 0527-2244

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-2244	FEBUXOSTAT	febuxostat	Lannett Company, Inc.	ANDA	Current
0527-2244	FEBUXOSTAT	febuxostat	Lannett Company, Inc.	ANDA	Current
0527-2248	FEBUXOSTAT	febuxostat	Lannett Company, Inc.	ANDA	Current
0527-2248	FEBUXOSTAT	febuxostat	Lannett Company, Inc.	ANDA	Current
48792-7905	FEBUXOSTAT	febuxostat	Sunshine Lake Pharma Co., Ltd.	ANDA	Current
48792-7906	FEBUXOSTAT	febuxostat	Sunshine Lake Pharma Co., Ltd.	ANDA	Current