Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075298
Company: WAYLIS THERAP
Company: WAYLIS THERAP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUTAMIDE | FLUTAMIDE | 125MG | CAPSULE;ORAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/18/2001 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75298TA.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75298ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/05/2002 | SUPPL-1 | Labeling |
Label is not available on this site. |