ApprovalTrail

Approval · Notice of Compliance 25740 · 2021

PROMETRIUM: Notice of Compliance 25740

Issued April 26, 2021

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
25740
Date
April 26, 2021
Company
Organon Canada Inc.Kirkland, Quebec, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Addition of alternate drug substance manufacturing,L packaging and testing site

Products in this notice

BrandDINStatus today
PROMETRIUMNot yet assigned—

Medicinal ingredients