Orange Book product · Brand (NDA)

ONTRALFY

TIZANIDINE HYDROCHLORIDE

Brand (NDA)NDA 216190RX FIDELITY BIOPHARMA

Dec 12, 2024

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 12, 2024
1 yr 6 mo ago
Today
Patent 12042484 expires
Listed drug product patent expiration.
May 07, 2042
in 16 yr 1 mo
Patent 12263158 expires
Listed drug product patent expiration.
May 07, 2042
in 16 yr 1 mo

Active ingredient

TIZANIDINE HYDROCHLORIDE

Strength

EQ 2MG BASE/5ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 216190

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
12042484	May 07, 2042	in 16 yr 1 mo	ProductU-2779
12263158	May 07, 2042	in 16 yr 1 mo	ProductU-2779