Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019842
Company: MCNEIL CONSUMER

Products on NDA 19842

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MOTRIN	IBUPROFEN	100MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SUSPENSION;ORAL	Discontinued	None	Yes	No

Labels for NDA 019842

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/10/2007	SUPPL-20	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019842s020lbl.pdf
01/24/2006	SUPPL-19	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019842s019lbl.pdf