Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062698
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 125MG BASE/5ML | FOR SUSPENSION;ORAL | Discontinued | None | No | No |
| CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 250MG BASE/5ML | FOR SUSPENSION;ORAL | Discontinued | None | No | No |
| CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 500MG BASE/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 |
|---|---|---|---|---|---|---|---|
| 03/01/1989 | 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 |
|---|---|---|---|---|---|
| 08/13/2014 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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| 11/20/1992 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 11/20/1992 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/20/1992 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/26/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/26/1991 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/26/1991 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |