Drugs@FDA: FDA-Approved Drugs
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CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/17/1978 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/05/2007 | SUPPL-46 | Labeling |
Label (PDF)
Letter (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 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050512s046, 050527s022, 050528s020ltr.pdf |
| 12/16/2003 | SUPPL-45 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50512slr045,50527slr021,50528slr019_duricef_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50512slr045,50527slr021,50528slr019ltr.pdf | |
| 05/03/2002 | SUPPL-44 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50512s44lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50512s044ltr.pdf | |
| 10/15/1996 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 12/05/1995 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 01/20/1982 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 11/02/1981 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/02/1981 | SUPPL-38 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/27/1981 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/24/1981 | SUPPL-36 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/18/1981 | SUPPL-35 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/21/1981 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 04/03/1981 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 02/22/1980 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 01/31/1980 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 01/21/1980 | SUPPL-29 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 01/24/1980 | SUPPL-28 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 12/28/1979 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 10/25/1979 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 04/26/1979 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/30/1979 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/05/1980 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/26/1979 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 08/14/1978 | SUPPL-20 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 07/21/1978 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/07/1978 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/08/1978 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 05/08/1978 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 09/12/1988 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/18/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 08/30/1991 | SUPPL-11 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 11/18/1987 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/12/1986 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 07/17/1982 | SUPPL-5 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 07/08/1983 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/21/1982 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| 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 |