ApprovalTrail

Drug · DIN 02391678

SUBLINOX

Yes: authorized and sold in Canada

Authorized, and the company reports that it sells it in Canada.

Status Marketed since July 5, 2019; first marketed January 28, 2013.
Drug Identification Number (DIN)
02391678
Company (DIN owner)
Bausch Health, Canada Inc.Laval, Quebec, Canada
Schedule
Targeted substances (cdsa iv)
Dosage form
Tablet (Orally-Disintegrating)
Route
Sublingual
Therapeutic class (ATC)
Zolpidem N05CF02
Class
Human
Record last updated
March 22, 2025

Active ingredients

As listed in the Drug Product Database.

IngredientStrengthPer
ZOLPIDEM TARTRATE5 MG

Notices of Compliance

Health Canada approvals that name this DIN.

  • July 5, 2019: NOC 22369New Drug Submission (NDS) · Change in product ownership
  • January 8, 2015: NOC 16505New Drug Submission (NDS) · Transfer of drug identification number
  • August 27, 2012: NOC 13588Supplement to a New Drug Submission (SNDS) · New strength and patient population: 5 mg tablet )orally disinegrating) for use in the elderly and in patients with hepatic impairment.

Recalls and safety alerts that mention it

Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “sublinox”. A notice may cover another product or only some lots: read it to see what it covers.

Other DINs named SUBLINOX