← FDA DRUG APPROVALS

FDA NDA · NDA021485

CARBIDOPA, LEVODOPA, AND ENTACAPONE

Sponsor: ORION PHARMA

APPLICATION
NDA021485
TYPE
NDA
ORIGINAL APPROVAL
2003-06-11
LATEST ACTION
2026-03-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

STALEVO 75 · ReferencePrescription
CARBIDOPA 18.75MG, ENTACAPONE 200MG, LEVODOPA 75MG · TABLET · ORAL
STALEVO 150 · ReferencePrescription
CARBIDOPA 37.5MG, ENTACAPONE 200MG, LEVODOPA 150MG · TABLET · ORAL
STALEVO 50 · ReferencePrescription
CARBIDOPA 12.5MG, ENTACAPONE 200MG, LEVODOPA 50MG · TABLET · ORAL
STALEVO 125 · ReferencePrescription
CARBIDOPA 31.25MG, ENTACAPONE 200MG, LEVODOPA 125MG · TABLET · ORAL
STALEVO 200 · ReferencePrescription
CARBIDOPA 50MG, ENTACAPONE 200MG, LEVODOPA 200MG · TABLET · ORAL
STALEVO 100 · ReferencePrescription
CARBIDOPA 25MG, ENTACAPONE 200MG, LEVODOPA 100MG · TABLET · ORAL

Approval history

2026-03-19Labeling · Supplement 48 · standard — Letter ↗AP
2019-12-30Labeling · Supplement 42 · standard — Letter ↗AP
2018-09-21UNKNOWN · Supplement 38 · standard — Letter ↗AP
2016-02-25Manufacturing (CMC) · Supplement 36 · standardAP
2016-02-22Labeling · Supplement 33 · standard — Letter ↗AP
2016-02-18Manufacturing (CMC) · Supplement 35 · standard — Label ↗AP
2016-01-29Manufacturing (CMC) · Supplement 34 · standardAP
2014-07-18Labeling · Supplement 29 · standard — Letter ↗AP
2014-07-18Labeling · Supplement 28 · standard — Letter ↗AP
2014-02-14Manufacturing (CMC) · Supplement 32 · standardAP
2014-01-16Manufacturing (CMC) · Supplement 30 · standardAP
2013-04-05Manufacturing (CMC) · Supplement 25 · standardAP
2010-10-11Labeling · Supplement 20 · standard — Letter ↗AP
2009-02-02Labeling · Supplement 12 · standard — Label ↗AP
2009-02-02Labeling · Supplement 8 · standard — Label ↗AP
2008-09-26Labeling · Supplement 17 · standard — Letter ↗AP
2008-08-29Manufacturing (CMC) · Supplement 16 — Label ↗AP
2007-08-02Manufacturing (CMC) · Supplement 11 · standard — Label ↗AP
2003-06-11Type 4 - New Combination · Original · standard — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

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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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