Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205414
Company: WEST-WARD PHARMS INT
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/15/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205414Orig1s000TAltr.pdf

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 PHARMS LTD
FEBUXOSTAT FEBUXOSTAT 40MG TABLET;ORAL Prescription No AB 205385 MYLAN
FEBUXOSTAT FEBUXOSTAT 40MG TABLET;ORAL Prescription No AB 205467 SUN PHARM
FEBUXOSTAT FEBUXOSTAT 40MG TABLET;ORAL Prescription No AB 205414 WEST-WARD PHARMS INT
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 PHARMS LTD
FEBUXOSTAT FEBUXOSTAT 80MG TABLET;ORAL Prescription No AB 205385 MYLAN
FEBUXOSTAT FEBUXOSTAT 80MG TABLET;ORAL Prescription No AB 205467 SUN PHARM
FEBUXOSTAT FEBUXOSTAT 80MG TABLET;ORAL Prescription No AB 205414 WEST-WARD PHARMS INT
ULORIC FEBUXOSTAT 80MG TABLET;ORAL Prescription Yes AB 021856 TAKEDA PHARMS USA

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