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FDA NDA · NDA212489

ONGENTYS

opicapone

Sponsor: AMNEAL

APPLICATION
NDA212489
TYPE
NDA
ORIGINAL APPROVAL
2020-04-24
LATEST ACTION
2025-10-10
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

ONGENTYS · ReferencePrescription
OPICAPONE 50MG · CAPSULE · ORAL
ONGENTYS · ReferencePrescription
OPICAPONE 25MG · CAPSULE · ORAL

Approval history

2025-10-10Labeling · Supplement 11 · standard — Label ↗AP
2025-02-07Labeling · Supplement 7 · standard — Letter ↗AP
2020-04-24Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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