ApprovalTrail

Drug · DIN 02242518

ACTONEL

No: no longer authorized

The company stopped selling it and its DIN was cancelled. A cancellation is most often a business decision; the record does not say why.

Status Cancelled Post Market since January 4, 2019; first marketed July 25, 2000.
Drug Identification Number (DIN)
02242518
Company (DIN owner)
Allergan Pharma Co.Markham, Ontario, Canada
Schedule
Prescription
Dosage form
Tablet
Route
Oral
Therapeutic class (ATC)
Risedronic acid M05BA07
Class
Human
Record last updated
March 22, 2025

Active ingredients

As listed in the Drug Product Database.

IngredientStrengthPer
RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)5 MG

Notices of Compliance

Health Canada approvals that name this DIN.

  • 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
  • July 17, 2000: NOC 1444Supplement to a New Drug Submission (SNDS) · New indication: treatment and prevention of postmenopausal osteoporosis, new strength

Other DINs named ACTONEL