Details for New Drug Application (NDA): 217645
✉ Email this page to a colleague
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-four suppliers are listed for this compound. Additional details are available on the clonidine hydrochloride profile page.
The generic ingredient in ONYDA XR is clonidine hydrochloride. There are twenty-two drug master file entries for this compound. Forty-four 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: | ⤷ Sign Up | 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: | ⤷ Sign Up | Patent Expiration: | Mar 29, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Complete Access Available with Subscription
