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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050527
Company: WARNER CHILCOTT

Products on NDA 050527

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DURICEF	CEFADROXIL/CEFADROXIL HEMIHYDRATE	EQ 500MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION;ORAL	Discontinued	None	Yes	No
DURICEF	CEFADROXIL/CEFADROXIL HEMIHYDRATE	EQ 125MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION;ORAL	Discontinued	None	Yes	No
DURICEF	CEFADROXIL/CEFADROXIL HEMIHYDRATE	EQ 250MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050527

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/12/1980	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-22	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-21	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-20	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
03/26/1999	SUPPL-19	Manufacturing (CMC)-Packaging		Label is not available on this site.
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.
05/21/1982	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
01/20/1982	SUPPL-12	Labeling		Label is not available on this site.
05/03/1989	SUPPL-11	Labeling		Label is not available on this site.
09/12/1988	SUPPL-10	Manufacturing (CMC)-Formulation		Label is not available on this site.
08/30/1991	SUPPL-9	Efficacy-New Dosing Regimen		Label is not available on this site.
10/27/1981	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
03/05/1987	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
08/07/1981	SUPPL-5	Labeling		Label is not available on this site.
06/30/1981	SUPPL-4	Labeling		Label is not available on this site.
03/31/1981	SUPPL-3	Labeling		Label is not available on this site.
12/08/1980	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
11/04/1980	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 050527

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/05/2007	SUPPL-22	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-21	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50512slr045,50527slr021,50528slr019_duricef_lbl.pdf
05/03/2002	SUPPL-20	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50512s44lbl.pdf

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