Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078810
Company: FRESENIUS KABI ONCOL
Company: FRESENIUS KABI ONCOL
| 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 |
|---|---|---|---|---|---|---|---|
| 08/07/2009 | ORIG-1 | Approval |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078810s000lbl.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/07/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078810s000lbl.pdf |