Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 018766
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANSAID FLURBIPROFEN 50MG TABLET;ORAL Discontinued None No No
ANSAID FLURBIPROFEN 100MG TABLET;ORAL Discontinued None No No
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.

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English