ApprovalTrail

Approval · Notice of Compliance 22833 · 2019

FUCITHALMIC: Notice of Compliance 22833

Issued October 29, 2019

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
22833
Date
October 29, 2019
Company
Amdipharm LimitedNorthwood, Dublin, Ireland
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Labelling Only
Reason
To update the Product Monograph (PM) with Level III and format changes, and to update the labels to align with Plain Language Labelling (PLL) Guidelines.

Products in this notice

BrandDINStatus today
FUCITHALMICNot yet assigned—

Medicinal ingredients