Drugs@FDA: FDA-Approved Drugs
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| DOLOBID | DIFLUNISAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| DOLOBID | DIFLUNISAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 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. |
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| 10/27/1983 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 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 |