Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019583
Company: SMITHKLINE BEECHAM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RELAFEN NABUMETONE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
RELAFEN NABUMETONE 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
12/24/1991 ORIG-1 Approval Type 1 - New Molecular Entity 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
01/24/2006 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019583s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019583s025ltr.pdf
08/11/2005 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019583s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019583s023ltr.pdf
06/14/2001 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

10/11/2001 SUPPL-19 Labeling

Label is not available on this site.

08/02/1999 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/03/1998 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/24/1996 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/18/1996 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

07/14/1995 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

05/10/1995 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

01/04/1995 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

10/26/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/22/1994 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

11/23/1993 SUPPL-5 Labeling

Label is not available on this site.

11/23/1993 SUPPL-4 Labeling

Label is not available on this site.

01/25/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/24/2006 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019583s025lbl.pdf
08/11/2005 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019583s023lbl.pdf

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