Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050406
Company: PRAGMA

Products on NDA 50406

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KEFLEX	CEPHALEXIN	EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	FOR SUSPENSION;ORAL	Discontinued	None	Yes	No
KEFLEX	CEPHALEXIN	EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons*	FOR SUSPENSION;ORAL	Discontinued	None	Yes	No
KEFLEX	CEPHALEXIN	EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons*	FOR SUSPENSION;ORAL	Discontinued	None	Yes	No

Labels for NDA 050406

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/05/2026	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050406s014lbl.pdf
12/18/2018	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050406s013lbl.pdf