Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050528
Company: WARNER CHILCOTT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DURICEF CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 1GM BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
08/06/1980 ORIG-1 Approval Type 3 - New Dosage Form 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-20 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-19 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-18 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-17 Labeling

Label is not available on this site.

12/05/1995 SUPPL-16 Labeling

Label is not available on this site.

02/28/1990 SUPPL-13 Labeling

Label is not available on this site.

09/12/1988 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

08/30/1991 SUPPL-9 Efficacy-New Dosing Regimen

Label is not available on this site.

11/18/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/12/1986 SUPPL-5 Labeling

Label is not available on this site.

07/08/1983 SUPPL-3 Manufacturing (CMC)-Packaging

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-20 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-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50512slr045,50527slr021,50528slr019_duricef_lbl.pdf
05/03/2002 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50512s44lbl.pdf

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