Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050512
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CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No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

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