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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 217645
Company: TRIS PHARMA INC

Products on NDA 217645

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ONYDA XR	CLONIDINE HYDROCHLORIDE	0.1MG/ML	SUSPENSION, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 217645

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/24/2024	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217645s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217645Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/217645Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/07/2025	SUPPL-4	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217645s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/217645Orig1s004ltr.pdf
12/06/2024	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217645s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217645Orig1s001ltr.pdf

Labels for NDA 217645

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/07/2025	SUPPL-4	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217645s004lbl.pdf
05/07/2025	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217645s004lbl.pdf
12/06/2024	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217645s001lbl.pdf
05/24/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217645s000lbl.pdf

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