Details for New Drug Application (NDA): 217645

NDA 217645 describes ONYDA XR, which is a drug marketed by Tris Pharma Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ONYDA XR profile page.

The generic ingredient in ONYDA XR is clonidine hydrochloride. There are twenty-two drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the clonidine hydrochloride profile page.

Summary for 217645

Tradename:	ONYDA XR
Applicant:	Tris Pharma Inc
Ingredient:	clonidine hydrochloride
Patents:	2

Pharmacology for NDA: 217645

Mechanism of Action

Adrenergic alpha2-Agonists

Suppliers and Packaging for NDA: 217645

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ONYDA XR	clonidine hydrochloride	SUSPENSION, EXTENDED RELEASE;ORAL	217645	NDA	NextWave Pharmaceuticals, Inc	24478-148	24478-148-01	7 mL in 1 BOTTLE (24478-148-01)
ONYDA XR	clonidine hydrochloride	SUSPENSION, EXTENDED RELEASE;ORAL	217645	NDA	NextWave Pharmaceuticals, Inc	24478-148	24478-148-02	120 mL in 1 BOTTLE (24478-148-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION, EXTENDED RELEASE;ORAL			Strength	0.1MG/ML
Approval Date:	May 24, 2024	TE:		RLD:	Yes
Patent:	11,918,689	Patent Expiration:	Jul 28, 2041	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD FOR DELIVERING AN EFFECTIVE AMOUNT OF CLONIDINE FOR A 24-HOUR PERIOD USING A SINGLE ORAL CLONIDINE COMPOSITION ACCORDING TO CLAIM 1 PRIOR TO BED TIME
Patent:	8,062,667	Patent Expiration:	Mar 29, 2029	Product Flag?	Y	Substance Flag?		Delist Request?

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