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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020697
Company: BAUSCH

Products on NDA 020697

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020697

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.

Labels for NDA 020697

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

Therapeutic Equivalents for NDA 020697

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

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