Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089508
Company: BEDFORD
Company: BEDFORD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUOROURACIL | FLUOROURACIL | 50MG/ML | INJECTABLE;INJECTION | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 01/26/1988 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/16/1989 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 07/20/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/18/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |