ApprovalTrail

Approval · Notice of Compliance 9074 · 2007

AVANDIA: Notice of Compliance 9074

Issued October 5, 2007

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
9074
Date
October 5, 2007
Company
Glaxosmithkline IncMississauga, Ontario, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Revisions to the dosage and administration section of the product monograph: use in combination with a sulfonylurea should not exceed 4 mg daily
Therapeutic class
Antidiabetic agent / insulin resistance reducing agent

Products in this notice

BrandDINStatus today
AVANDIANot yet assigned—

Medicinal ingredients