Drugs@FDA: FDA-Approved Drugs
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| CLINORIL | SULINDAC | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| CLINORIL | SULINDAC | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |