Application 205421

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

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
A205421-001	FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET / ORAL	AB		2019-07-01
A205421-002	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
A205421-001	AB
A205421-002	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 · 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	A205421-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205421-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205421-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205421-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205421-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205421-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205421-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205421-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205421-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205421-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205421-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205421-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205421-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205421-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205421-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205421-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205421-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205421-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205421-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205421-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205421-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205421-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205421-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205421-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205421-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205421-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205421-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205421-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205421-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205421-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205421-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205421-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205421-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205421-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205421-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205421-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205421-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205421-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205421-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205421-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A205421-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205421-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205421-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205421-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205421-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205421-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205421-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205421-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205421-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205421-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205421-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205421-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205421-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205421-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205421-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205421-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205421-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205421-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205421-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205421-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205421-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205421-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205421-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205421-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205421-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205421-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205421-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205421-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205421-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205421-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205421-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205421-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205421-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205421-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205421-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205421-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205421-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205421-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205421-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205421-002	AB	1	`bb7c543d1eb4…`

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	Alembic Pharmaceuticals Inc.	9a87099f-d82d-42c7-872a-b87d3917e960	2023-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205421 application number: ANDA205421 ndc (product): 62332-190 ndc (product): 62332-191
Febuxostat	FEBUXOSTAT	Alembic Pharmaceuticals Limited	41a95424-046e-413b-a121-cd7335e67135	2023-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205421 application number: ANDA205421 ndc (product): 46708-190 ndc (product): 46708-191

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-190	Febuxostat	febuxostat	Alembic Pharmaceuticals Limited	ANDA	Current
46708-191	Febuxostat	febuxostat	Alembic Pharmaceuticals Limited	ANDA	Current
62332-190	Febuxostat	febuxostat	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-190	Febuxostat	febuxostat	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-190	Febuxostat	febuxostat	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-191	Febuxostat	febuxostat	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-191	Febuxostat	febuxostat	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-191	Febuxostat	febuxostat	Alembic Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32670	ORIG	2016-07-05