ApprovalTrail

Approval · Notice of Compliance 14831 · 2013

FOSAMAX: Notice of Compliance 14831

Issued October 21, 2013

A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.

Notice number
14831
Date
October 21, 2013
Company
Merck Canada IncKirkland, Quebec, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Revisions to the following sections of the product monograph due to the discontinuation of the 40 mg tablet and 70 mg/ 70ml oral solution summary product information, indications and clinical use, adverse reactions, action and clinical pharmacology, dosage forms, composition and packaging, clinical trials, and part III consumer information
Therapeutic class
Bone metabolism regulator

Products in this notice

BrandDINStatus today
FOSAMAXNot yet assigned—

Medicinal ingredients