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FDA NDA · NDA209449

NITYR

nitisinone

Sponsor: CYCLE

APPLICATION
NDA209449
TYPE
NDA
ORIGINAL APPROVAL
2017-07-26
LATEST ACTION
2025-06-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

HARLIKU · ReferencePrescription
NITISINONE 2MG · TABLET · ORAL
NITYR · ReferencePrescription
NITISINONE 5MG · TABLET · ORAL
NITYR · ReferencePrescription
NITISINONE 10MG · TABLET · ORAL
NITYR · ReferencePrescription
NITISINONE 2MG · TABLET · ORAL

Approval history

2025-06-10Efficacy · Supplement 18 · priority — Label ↗AP
2024-01-18Labeling · Supplement 17 · standard — Letter ↗AP
2020-09-02Efficacy · Supplement 5 · standard — Letter ↗AP
2018-11-05Labeling · Supplement 6 · standard — Label ↗AP
2017-07-26Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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