Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050406
Company: PRAGMA

Products on NDA 050406

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KEFLEX	CEPHALEXIN	EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	FOR SUSPENSION;ORAL	Discontinued	None	Yes	No
KEFLEX	CEPHALEXIN	EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons*	FOR SUSPENSION;ORAL	Discontinued	None	Yes	No
KEFLEX	CEPHALEXIN	EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons*	FOR SUSPENSION;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050406

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/04/1971	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	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
12/18/2018	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050406s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050406Orig1s013ltr.pdf
05/15/1996	SUPPL-12	Labeling		Label is not available on this site.
05/19/2009	SUPPL-11	Labeling		Label is not available on this site.
02/13/1995	SUPPL-10	Labeling		Label is not available on this site.
08/27/1992	SUPPL-8	Labeling		Label is not available on this site.
04/10/1990	SUPPL-7	Labeling		Label is not available on this site.

Labels for NDA 050406

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