An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 050528
Company: WARNER CHILCOTT

Products on NDA 050528

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CEFADROXIL/CEFADROXIL HEMIHYDRATE	EQ 1GM BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050528

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.

Labels for NDA 050528

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

Top