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 | Prescription | AB | Yes | Yes |
TASMAR | TOLCAPONE | 200MG | TABLET;ORAL | Discontinued | None | No | 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 |
---|---|---|---|---|---|---|---|
01/29/1998 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20697lbl-s4.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20697ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20697_Tasmar.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/30/2013 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/30/2014 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/30/2009 | SUPPL-16 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020697s016ltr.pdf |
02/09/2009 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020697s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020697s013,020697s015ltr.pdf | |
02/09/2009 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020697s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020697s013,020697s015ltr.pdf | |
01/24/2007 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020697s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020697s012ltr.pdf | |
02/17/2006 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020697s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020697s010ltr.pdf | |
01/24/2001 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/22/2000 | SUPPL-5 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
05/11/2013 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020697s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020697Orig1s004ltr.pdf | |
11/16/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
04/24/1998 | 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 |
---|---|---|---|---|---|
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 |
TASMAR
TABLET;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TASMAR | TOLCAPONE | 100MG | TABLET;ORAL | Prescription | Yes | AB | 020697 | BAUSCH |
TOLCAPONE | TOLCAPONE | 100MG | TABLET;ORAL | Prescription | No | AB | 208937 | NOVAST LABS |