Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018445
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOLOBID DIFLUNISAL 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
DOLOBID DIFLUNISAL 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
04/19/1982 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/16/2007 SUPPL-58 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018445s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018445s058ltr.pdf
01/24/2006 SUPPL-57 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018445s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018445s057ltr.pdf
12/01/1997 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

05/15/1998 SUPPL-53 Labeling

Label is not available on this site.

05/15/1998 SUPPL-52 Labeling

Label is not available on this site.

03/01/1996 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

04/17/1997 SUPPL-50 Labeling

Label is not available on this site.

08/18/1994 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

08/22/1994 SUPPL-48 Labeling

Label is not available on this site.

08/22/1994 SUPPL-47 Labeling

Label is not available on this site.

08/22/1994 SUPPL-46 Labeling

Label is not available on this site.

12/06/1991 SUPPL-44 Labeling

Label is not available on this site.

12/06/1991 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

11/19/1991 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

01/09/1989 SUPPL-40 Labeling

Label is not available on this site.

01/09/1989 SUPPL-38 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/21/1989 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

01/09/1989 SUPPL-36 Labeling

Label is not available on this site.

05/03/1988 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

02/02/1988 SUPPL-34 Labeling

Label is not available on this site.

02/02/1988 SUPPL-33 Labeling

Label is not available on this site.

02/02/1988 SUPPL-32 Labeling

Label is not available on this site.

02/02/1988 SUPPL-31 Labeling

Label is not available on this site.

02/02/1988 SUPPL-30 Labeling

Label is not available on this site.

03/28/1994 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

02/02/1988 SUPPL-27 Labeling

Label is not available on this site.

08/15/1986 SUPPL-26 Labeling

Label is not available on this site.

08/15/1986 SUPPL-25 Labeling

Label is not available on this site.

02/02/1988 SUPPL-24 Labeling

Label is not available on this site.

04/21/1989 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/03/1986 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1985 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

02/21/1985 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/21/1985 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/20/1984 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/03/1984 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/11/1984 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

05/03/1984 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/25/1984 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/09/1985 SUPPL-8 Labeling

Label is not available on this site.

10/27/1983 SUPPL-7 Labeling

Label is not available on this site.

10/27/1983 SUPPL-3 Labeling

Label is not available on this site.

02/03/1986 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/16/2007 SUPPL-58 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018445s058lbl.pdf
01/24/2006 SUPPL-57 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018445s057lbl.pdf

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