Drugs@FDA: FDA-Approved Drugs
Company: ORTHO MCNEIL JANSSEN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TOLECTIN DS | TOLMETIN SODIUM | EQ 400MG BASE | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 10/30/1979 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 01/22/2008 | SUPPL-52 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018084s052,017628s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018084s052ltr.pdf | |
| 02/09/2006 | SUPPL-51 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017628s067,018084s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018084s051,017628s067ltr.pdf | |
| 12/19/2000 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/25/2000 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/1996 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/18/1993 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/21/1993 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/02/1991 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/1991 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 07/11/1991 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/18/1989 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/1989 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/30/1989 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/30/1989 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/02/1987 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/31/1986 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/31/1986 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/11/1985 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 12/11/1985 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 12/11/1985 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 02/07/1985 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 10/05/1984 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/03/1984 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/15/1985 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/18/1985 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 04/06/1983 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/25/1983 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1983 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 01/31/1983 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 04/29/1988 | SUPPL-12 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 01/15/1985 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/16/1983 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/18/1985 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 07/27/1982 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/12/1982 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1981 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/21/1981 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/12/1981 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/22/2008 | SUPPL-52 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018084s052,017628s068lbl.pdf | |
| 02/09/2006 | SUPPL-51 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017628s067,018084s051lbl.pdf |