Details for New Drug Application (NDA): 216190
✉ Email this page to a colleague
NDA 216190 describes ONTRALFY, which is a drug marketed by Fidelity Biopharma 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 ONTRALFY profile page.
The generic ingredient in ONTRALFY is tizanidine hydrochloride. There are eleven drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the tizanidine hydrochloride profile page.
The generic ingredient in ONTRALFY is tizanidine hydrochloride. There are eleven drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the tizanidine hydrochloride profile page.
Summary for 216190
| Tradename: | ONTRALFY |
| Applicant: | Fidelity Biopharma |
| Ingredient: | tizanidine hydrochloride |
| Patents: | 2 |
Pharmacology for NDA: 216190
| Mechanism of Action | Adrenergic alpha2-Agonists |
Suppliers and Packaging for NDA: 216190
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ONTRALFY | tizanidine hydrochloride | SOLUTION;ORAL | 216190 | NDA | Rosemont Pharmaceuticals, LLC | 69528-310 | 69528-310-16 | 473 mL in 1 BOTTLE, PLASTIC (69528-310-16) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 2MG BASE/5ML | ||||
| Approval Date: | Dec 12, 2024 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | May 7, 2042 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF SPASTICITY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | May 7, 2042 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF SPASTICITY | ||||||||
Complete Access Available with Subscription
