ApprovalTrail

Drug · DIN 02316838

ACTONEL

Yes: authorized and sold in Canada

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

Status Marketed since May 5, 2025; first marketed December 1, 2008.
Drug Identification Number (DIN)
02316838
Company (DIN owner)
AbbVie CorporationSaint-Laurent, Quebec, Canada
Schedule
Prescription
Dosage form
Tablet
Route
Oral
Therapeutic class (ATC)
Risedronic acid M05BA07
Class
Human
Record last updated
June 17, 2025

Active ingredients

As listed in the Drug Product Database.

IngredientStrengthPer
RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)150 MG

Notices of Compliance

Health Canada approvals that name this DIN.

  • November 4, 2022: NOC 29396New Drug Submission (NDS) · Administrative: Merger/Buy-out
  • March 15, 2019: NOC 21979New Drug Submission (NDS) · Merger - buyout and updates to the inner and outer labels based on changes to the die-lines
  • August 3, 2017: NOC 19621New Drug Submission (NDS) · Change to the DIN owner Removing the 75mg strength Change in Part III to the 2014 Patient Mediciation Information (PMI) format and changes to the package inserts and product labels
  • May 1, 2017: NOC 19224Supplement to a New Drug Submission (SNDS) · Update to the product monograph regarding osteonecrosis of the jaw (onj) in response to an advisement letter
  • February 18, 2010: NOC 11062New Drug Submission (NDS) · Manufacturer name change
  • September 24, 2008: NOC 9795Supplement to a New Drug Submission (SNDS) · New strength: 150 mg tablet and new dosing regimen

Other DINs named ACTONEL