Application 211339

Type: ANDA
Sponsor: BEIJING SL PHARMA CO 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.

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 2 of 2 · 26 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	Name fallback brand name: Febuxostat generic name: FEBUXOSTAT
Febuxostat	FEBUXOSTAT	Alembic Pharmaceuticals Limited	41a95424-046e-413b-a121-cd7335e67135	2023-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Febuxostat generic name: FEBUXOSTAT
Febuxostat	FEBUXOSTAT	Ascend Laboratories, LLC	154ad94e-b775-4a10-ab0f-2874a0782db9	2022-09-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Febuxostat generic name: FEBUXOSTAT
Febuxostat	FEBUXOSTAT	Aphena Pharma Solutions - Tennessee, LLC	bc986925-fd24-4865-997c-ede55c2faffc	2020-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Febuxostat generic name: FEBUXOSTAT
Febuxostat	FEBUXOSTAT	Aphena Pharma Solutions - Tennessee, LLC	bf4d29c8-4731-42bc-887a-d8302add9ca9	2020-04-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Febuxostat generic name: FEBUXOSTAT
Febuxostat	FEBUXOSTAT	DR REDDY'S LABORATORIES LIMITED	ccf2c4b1-e9a3-c7b7-ac42-79e1988fc211	2019-09-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Febuxostat generic name: FEBUXOSTAT

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.