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OTIXAL - Health Canada Drug Approval Details

Approvals/Health Canada/OTIXAL

Authorized

STANDARD

OTIXAL

medexus pharmaceuticals inc.🇨🇦 Health Canada

Approval Date: Jul 4, 2025
Approval ID: 103ac55dc3699b1e
Company: medexus pharmaceuticals inc.
Type: Standard

Approval Details

Approval Id: 103ac55dc3699b1e
Drug Approval Canada Name: OTIXAL
Product Name: OTIXAL
Status: Marketed
Status Date: 2023-01-25
Original Market Date: 2017-05-08
Din: 02459655
Drug Class: Human
Dosage Form: Solution
Route Of Administration: Otic
Schedule: Prescription
Ahfs: 52:08.08
Atc Original: S02CA05 FLUOCINOLONE ACETONIDE AND ANTIINFECTIVES
Atc Name: s 02 ca 05
Aig Number: 0258670001
Company Name: medexus pharmaceuticals inc.
Company Address: 35 Nixon Road, Unit 10, Bolton, Ontario, Canada, L7E 1K1

Active Ingredients

FLUOCINOLONE ACETONIDE

0.025 % / W/V

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE)

0.3 % / W/V

Authorized

Quick Info

Agency

Health Canada

Country

🇨🇦

Approval Date

Jul 4, 2025

Approval ID

103ac55dc3699b1e

Type

Standard

Back to Health Canada Approvals