Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017463
Company: MCNEIL CONSUMER

• Medication Guide

Products on NDA 17463

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MOTRIN	IBUPROFEN	400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
MOTRIN	IBUPROFEN	300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
MOTRIN	IBUPROFEN	600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
MOTRIN	IBUPROFEN	800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No

Labels for NDA 017463

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/10/2007	SUPPL-105	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017463s105lbl.pdf
01/24/2006	SUPPL-104	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017463s104lbl.pdf