Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 050405
Company: PRAGMA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KEFLEX	CEPHALEXIN	EQ 250MG BASE	CAPSULE;ORAL	Discontinued	None	Yes	No
KEFLEX	CEPHALEXIN	EQ 500MG BASE	CAPSULE;ORAL	Discontinued	None	Yes	No
KEFLEX	CEPHALEXIN	EQ 333MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued	None	Yes	No
KEFLEX	CEPHALEXIN	EQ 750MG BASE	CAPSULE;ORAL	Discontinued	None	Yes	No

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/19/2018	SUPPL-108	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050405s108lbl.pdf
12/18/2018	SUPPL-107	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050405s107lbl.pdf
10/30/2015	SUPPL-106	Labeling-Package Insert	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/2015/050405s106lbl.pdf
05/12/2006	SUPPL-97	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050405s097lbl.pdf
01/15/2004	SUPPL-94	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50405slr094_keflex_lbl.pdf