Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078803
Company: ACTAVIS TOTOWA
Company: ACTAVIS TOTOWA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OXALIPLATIN | OXALIPLATIN | 50MG/VIAL | INJECTABLE;INTRAVENOUS | Discontinued | None | No | No |
| OXALIPLATIN | OXALIPLATIN | 100MG/VIAL | INJECTABLE;INTRAVENOUS | 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 |
|---|---|---|---|---|---|---|---|
| 08/08/2012 | 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 |
|---|---|---|---|---|---|
| 11/29/2023 | SUPPL-7 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/31/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/31/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/20/2013 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |