FDA NDA · NDA020697

TASMAR

tolcapone

Sponsor: BAUSCH

APPLICATION

NDA020697

TYPE

NDA

ORIGINAL APPROVAL

1998-01-29

LATEST ACTION

2014-09-30

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Prescription, Discontinued

Products

TASMAR · ReferencePrescription

TOLCAPONE 100MG · TABLET · ORAL

TASMARDiscontinued

TOLCAPONE 200MG · TABLET · ORAL

2014-09-30Manufacturing (CMC) · Supplement 18 · standardAP

2013-05-11Labeling · Supplement 4 · standard — Letter ↗AP

2013-04-30Manufacturing (CMC) · Supplement 19 · standardAP

2009-06-30Manufacturing (CMC) · Supplement 16 — Letter ↗AP

2009-02-09Labeling · Supplement 15 · standard — Letter ↗AP

2009-02-09Labeling · Supplement 13 · standard — Label ↗AP

2007-01-24Labeling · Supplement 12 · standard — Label ↗AP

2006-02-17Labeling · Supplement 10 · standard — Label ↗AP

2001-01-24Manufacturing (CMC) · Supplement 6 · standardAP

2000-11-22Manufacturing (CMC) · Supplement 5 · standardAP

1998-11-16Labeling · Supplement 2 · standardAP

1998-04-24Manufacturing (CMC) · Supplement 1 · standardAP

1998-01-29Type 1 - New Molecular Entity · Original · standard — Review ↗AP

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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