Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020697
Company: BAUSCH
Company: BAUSCH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TASMAR | TOLCAPONE | 100MG | TABLET;ORAL | Discontinued | None | Yes | No |
| TASMAR | TOLCAPONE | 200MG | TABLET;ORAL | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/11/2013 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020697s004lbl.pdf | |
| 02/09/2009 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020697s013s015lbl.pdf | |
| 02/09/2009 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020697s013s015lbl.pdf | |
| 01/24/2007 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020697s012lbl.pdf | |
| 02/17/2006 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020697s010lbl.pdf | |
| 01/29/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20697lbl-s4.pdf |