ApprovalTrail

Approval · Notice of Compliance 37118 · 2026

MYLAN-HYDROXYUREA: Notice of Compliance 37118

Issued March 17, 2026

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
37118
Date
March 17, 2026
Company
Mylan Pharmaceuticals UlcEtobicoke, Ontario, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to an Abbreviated New Drug Submission (SANDS), supplement
Submission class
Other
Reason
Update to Product Monograph
Canadian reference product
HYDREA

Products in this notice

BrandDINStatus today
MYLAN-HYDROXYUREANot yet assigned—

Medicinal ingredients