Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062291
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 500MG BASE | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 07/30/1980 | 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 |
|---|---|---|---|---|---|
| 09/29/2009 | SUPPL-30 | Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 09/09/2005 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 10/20/1998 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 08/25/1998 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 12/11/1997 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 11/03/1997 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 12/29/1994 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 05/18/1989 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1991 | SUPPL-15 | Labeling |
Label is not available on this site. |