FDA NDA · NDA020796

ENTACAPONE

Sponsor: ORION PHARMA

APPLICATION

NDA020796

TYPE

NDA

ORIGINAL APPROVAL

1999-10-19

LATEST ACTION

2016-02-22

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Prescription

Products

COMTAN · ReferencePrescription

ENTACAPONE 200MG · TABLET · ORAL

2016-02-22Labeling · Supplement 26 · standard — Label ↗AP

2015-10-16Manufacturing (CMC) · Supplement 25 · standardAP

2015-01-16Labeling · Supplement 24 · standard — Label ↗AP

2014-06-13Labeling · Supplement 16 · standard — Letter ↗AP

2014-01-16Manufacturing (CMC) · Supplement 21 · standardAP

2013-10-11Manufacturing (CMC) · Supplement 22 · standardAP

2010-10-11Labeling · Supplement 15 · standard — Label ↗AP

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

2009-02-02Labeling · Supplement 12 · standard — Label ↗AP

2002-04-18Manufacturing (CMC) · Supplement 4 · standardAP

2002-01-17Manufacturing (CMC) · Supplement 3 · standardAP

2002-01-10Manufacturing (CMC) · Supplement 2 · standardAP

2001-08-14Manufacturing (CMC) · Supplement 1 · standardAP

1999-10-19Type 1 - New Molecular Entity · Original · standard — Label ↗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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