Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050512
Company: WARNER CHILCOTT
Company: WARNER CHILCOTT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DURICEF | CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| DURICEF | CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 250MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/05/2007 | SUPPL-46 | Labeling | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050512s046,050527s022,050528s020lbl.pdf |
| 12/16/2003 | SUPPL-45 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50512slr045,50527slr021,50528slr019_duricef_lbl.pdf | |
| 05/03/2002 | SUPPL-44 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50512s44lbl.pdf |