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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021378
Company: FOREST LABS

Medication Guide

Products on NDA 021378

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COMBUNOX	IBUPROFEN; OXYCODONE HYDROCHLORIDE	400MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021378

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/26/2004	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021378lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021378ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021378s000_CombunoxTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/02/2010	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021378s006lbl.pdf
06/20/2007	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021378s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021378s005ltr.pdf
03/02/2006	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021378s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021378s002ltr.pdf

Labels for NDA 021378

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/02/2010	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021378s006lbl.pdf
06/20/2007	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021378s005lbl.pdf
03/02/2006	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021378s002lbl.pdf
11/26/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021378lbl.pdf

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