← FDA DRUG APPROVALS

FDA NDA · NDA022075

NOURIANZ

istradefylline

Sponsor: KYOWA KIRIN

APPLICATION
NDA022075
TYPE
NDA
ORIGINAL APPROVAL
2019-08-27
LATEST ACTION
2019-08-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

NOURIANZ · ReferencePrescription
ISTRADEFYLLINE 40MG · TABLET · ORAL
NOURIANZ · ReferencePrescription
ISTRADEFYLLINE 20MG · TABLET · ORAL

Approval history

2019-08-27Type 1 - New Molecular Entity · 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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