Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062695
Company: TEVA
Company: TEVA
| 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 |
|---|---|---|---|---|---|---|---|
| 02/10/1989 | 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 |
|---|---|---|---|---|---|
| 04/16/2014 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/01/1992 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 04/29/1992 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/30/1989 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/01/1989 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/01/1989 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/23/1989 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |