Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076235
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARBOPLATIN | CARBOPLATIN | 50MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| CARBOPLATIN | CARBOPLATIN | 150MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| CARBOPLATIN | CARBOPLATIN | 450MG/VIAL | 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 |
|---|---|---|---|---|---|---|---|
| 10/14/2004 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76235ltr.pdf |