Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078812
Company: SANDOZ
Company: SANDOZ
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 |
---|---|---|---|---|---|---|---|
08/07/2009 | 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 |
---|---|---|---|---|---|
09/10/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
09/10/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
02/28/2013 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |