Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020697
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 210095 MAYNE PHARMA
TOLCAPONE TOLCAPONE 100MG TABLET;ORAL Prescription No AB 208937 NOVAST LABS
TOLCAPONE TOLCAPONE 100MG TABLET;ORAL Prescription No AB 204584 PAR PHARM INC

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