Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 081225
Company: TEVA PARENTERAL
Company: TEVA PARENTERAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADRUCIL | 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 |
|---|---|---|---|---|---|---|---|
| 08/28/1991 | 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 |
|---|---|---|---|---|---|
| 07/30/1999 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 09/12/1997 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 11/04/1992 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/10/1992 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1991 | SUPPL-1 | Labeling |
Label is not available on this site. |