Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017911
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLINORIL SULINDAC 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
CLINORIL SULINDAC 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
09/27/1978 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
12/23/2010 SUPPL-74 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017911s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017911s074ltr.pdf
06/04/2010 SUPPL-73 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017911s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017911s073ltr.pdf
03/30/2009 SUPPL-72 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017911s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017911s072ltr.pdf
08/23/2007 SUPPL-70 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017911s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017911s070ltr.pdf
01/24/2006 SUPPL-68 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017911s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017911s068ltr.pdf
02/07/2001 SUPPL-67 Manufacturing (CMC)-Control

Label is not available on this site.

10/30/2001 SUPPL-66 Labeling

Label is not available on this site.

10/05/2006 SUPPL-65 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017911s065_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017911s065ltr.pdf
04/14/1997 SUPPL-64 Manufacturing (CMC)-Control

Label is not available on this site.

05/02/1997 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/1996 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

10/24/1994 SUPPL-60 Manufacturing (CMC)-Control

Label is not available on this site.

08/18/1994 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

07/10/1995 SUPPL-58 Labeling

Label is not available on this site.

06/01/1995 SUPPL-57 Labeling

Label is not available on this site.

07/27/1992 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

05/31/1989 SUPPL-52 Labeling

Label is not available on this site.

05/31/1989 SUPPL-51 Labeling

Label is not available on this site.

01/09/1989 SUPPL-50 Labeling

Label is not available on this site.

02/06/1989 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

01/09/1989 SUPPL-47 Labeling

Label is not available on this site.

01/09/1989 SUPPL-46 Labeling

Label is not available on this site.

05/03/1988 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

01/09/1989 SUPPL-44 Labeling

Label is not available on this site.

01/09/1989 SUPPL-43 Labeling

Label is not available on this site.

01/09/1989 SUPPL-40 Labeling

Label is not available on this site.

02/05/1986 SUPPL-38 Labeling

Label is not available on this site.

02/05/1986 SUPPL-37 Labeling

Label is not available on this site.

02/05/1986 SUPPL-35 Labeling

Label is not available on this site.

11/26/1984 SUPPL-34 Labeling

Label is not available on this site.

07/26/1984 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

01/26/1984 SUPPL-31 Labeling

Label is not available on this site.

05/31/1989 SUPPL-27 Labeling

Label is not available on this site.

08/13/1984 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

05/29/1984 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1983 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

06/22/1982 SUPPL-20 Labeling

Label is not available on this site.

06/22/1982 SUPPL-18 Labeling

Label is not available on this site.

06/29/1982 SUPPL-17 Labeling

Label is not available on this site.

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

Label is not available on this site.

05/12/1993 SUPPL-15 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/27/1981 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/05/1981 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/21/1981 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/14/1981 SUPPL-9 Labeling

Label is not available on this site.

12/14/1981 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/08/1979 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1979 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

05/12/1981 SUPPL-5 Labeling

Label is not available on this site.

08/06/1979 SUPPL-4 Labeling

Label is not available on this site.

08/08/1979 SUPPL-3 Labeling

Label is not available on this site.

07/23/1979 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/14/1979 SUPPL-1 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/23/2010 SUPPL-74 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017911s074lbl.pdf
06/04/2010 SUPPL-73 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017911s073lbl.pdf
03/30/2009 SUPPL-72 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017911s072lbl.pdf
08/23/2007 SUPPL-70 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017911s070lbl.pdf
10/05/2006 SUPPL-65 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017911s065_lbl.pdf
01/24/2006 SUPPL-68 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017911s068lbl.pdf

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