Drugs@FDA: FDA-Approved Drugs
Company: JANSSEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VERMOX | MEBENDAZOLE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 06/28/1974 | 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 |
|---|---|---|---|---|---|
| 06/13/2017 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017481s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017481Orig1s047ltr.pdf | |
| 10/20/1998 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/27/1998 | SUPPL-44 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/20/1998 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/20/1998 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/27/1995 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/16/1994 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/13/1998 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 12/23/1993 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/28/1993 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1993 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/1989 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 01/26/1986 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/09/1984 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/31/1984 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/14/1984 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 03/16/1983 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/16/1983 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/1983 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 06/04/1981 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/29/1980 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/03/1980 | SUPPL-20 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/01/1980 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1980 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/08/1979 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 03/08/1979 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/13/1979 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/15/1979 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/1978 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/24/1978 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/24/1977 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 07/29/1977 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 03/04/1977 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/18/1976 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 10/30/1975 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/30/1975 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/18/1976 | SUPPL-3 | 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 |
|---|---|---|---|---|---|
| 06/13/2017 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017481s047lbl.pdf |