Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207562
Company: INGENUS PHARMS LLC
Company: INGENUS PHARMS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OXALIPLATIN | OXALIPLATIN | 50MG/10ML (5MG/ML) | INJECTABLE;INTRAVENOUS | Discontinued | None | No | No |
| OXALIPLATIN | OXALIPLATIN | 100MG/20ML (5MG/ML) | 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 |
|---|---|---|---|---|---|---|---|
| 10/16/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/22/2025 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/31/2022 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |