Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065257
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFPROZIL | CEFPROZIL | 125MG/5ML | FOR SUSPENSION;ORAL | Discontinued | None | No | No |
| CEFPROZIL | CEFPROZIL | 250MG/5ML | FOR SUSPENSION;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 12/08/2005 | 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 |
|---|---|---|---|---|---|
| 05/12/2017 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/08/2008 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 07/23/2007 | SUPPL-2 | Labeling |
Label is not available on this site. |