Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019508
Company: SMITHKLINE BEECHAM

Products on NDA 19508

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AXID	NIZATIDINE	150MG	CAPSULE;ORAL	Discontinued	None	No	No
AXID	NIZATIDINE	300MG	CAPSULE;ORAL	Discontinued	None	No	No

Labels for NDA 019508

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/23/2005	SUPPL-33	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019508s033lbl.pdf