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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018766
Company: PHARMACIA AND UPJOHN

Medication Guide

Products on NDA 018766

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ANSAID	FLURBIPROFEN	50MG	TABLET;ORAL	Discontinued	None	Yes	No
ANSAID	FLURBIPROFEN	100MG	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018766

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/1988	ORIG-1	Approval	Type 3 - New Dosage Form	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
05/09/2016	SUPPL-20	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018766s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018766Orig1s020ltr.pdf
08/13/2010	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018766s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018766s015ltr.pdf
06/21/2007	SUPPL-14	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018766s014ltr.pdf
01/24/2006	SUPPL-13	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018766s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018766s013ltr.pdf
12/13/1999	SUPPL-12	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/30/2001	SUPPL-11	Labeling		Label is not available on this site.
10/30/2001	SUPPL-10	Labeling		Label is not available on this site.
03/25/1994	SUPPL-8	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/25/1994	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
09/04/1991	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
09/06/1989	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
05/05/1989	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 018766

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/09/2016	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018766s020lbl.pdf
05/09/2016	SUPPL-20	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018766s020lbl.pdf
05/09/2016	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018766s020lbl.pdf
08/13/2010	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018766s015lbl.pdf
01/24/2006	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018766s013lbl.pdf

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