Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210461
Company: MSN
Company: MSN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FEBUXOSTAT | FEBUXOSTAT | 40MG | TABLET;ORAL | Prescription | BX | No | No |
FEBUXOSTAT | FEBUXOSTAT | 80MG | TABLET;ORAL | Prescription | BX | 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 |
---|---|---|---|---|---|---|---|
12/30/2019 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210461Orig1s000TAltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/15/2023 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
FEBUXOSTAT
There are no Therapeutic Equivalents.