← FDA DRUG APPROVALS

FDA NDA · NDA217645

ONYDA XR

clonidine hydrochloride

Sponsor: TRIS PHARMA INC

APPLICATION
NDA217645
TYPE
NDA
ORIGINAL APPROVAL
2024-05-24
LATEST ACTION
2025-05-07
ROUTE
ORAL
DOSAGE FORM
SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

ONYDA XR · ReferencePrescription
CLONIDINE HYDROCHLORIDE 0.1MG/ML · SUSPENSION, EXTENDED RELEASE · ORAL

Approval history

2025-05-07Labeling · Supplement 4 · standard — Letter ↗AP
2024-12-06Labeling · Supplement 1 · standard — Letter ↗AP
2024-05-24Type 3 - New Dosage Form · Original · standard — Label ↗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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