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ONTRALFY

NDA · New Drug Application · Sponsor: FIDELITY BIOPHARMA · Approved 2024-12-12

Drug application

FDA Application #

NDA216190

Application type

New Drug Application

Brand name

ONTRALFY

Generic name

TIZANIDINE HYDROCHLORIDE

Active ingredients

TIZANIDINE HYDROCHLORIDE

Dosage form

SOLUTION

Route

ORAL

Marketing status

Prescription

Sponsor

FIDELITY BIOPHARMA

Manufacturer

Rosemont Pharmaceuticals, LLC

First approval

2024-12-12

Source

Authoritative

Drugs@FDA application overview

Machine

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