Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018084
Company: ORTHO MCNEIL JANSSEN
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| TOLECTIN DS | TOLMETIN SODIUM | EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| 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 |