An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 205385
Company: MYLAN

Products on ANDA 205385

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	AB	No	No
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205385

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/01/2019	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205385Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 205385

FEBUXOSTAT

TABLET;ORAL; 40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	205421	ALEMBIC
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	212924	ALKEM LABS LTD
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	205374	DR REDDYS
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	205414	HIKMA
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	210292	INDOCO
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	210461	MSN
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	205385	MYLAN
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	206266	PRINSTON INC
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	205467	SUN PHARM
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	213069	SUNSHINE
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	205443	ZYDUS LIFESCIENCES
ULORIC	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	Yes	AB	021856	TAKEDA PHARMS USA

TABLET;ORAL; 80MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	205421	ALEMBIC
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	212924	ALKEM LABS LTD
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	205374	DR REDDYS
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	205414	HIKMA
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	210292	INDOCO
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	210461	MSN
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	205385	MYLAN
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	206266	PRINSTON INC
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	205467	SUN PHARM
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	213069	SUNSHINE
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	205443	ZYDUS LIFESCIENCES
ULORIC	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	Yes	AB	021856	TAKEDA PHARMS USA

Top