ApprovalTrail

Approval · Notice of Compliance 23463 · 2020

ABILIFY: Notice of Compliance 23463

Issued April 15, 2020

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
23463
Date
April 15, 2020
Company
Otsuka Pharmaceutical Co LtdChiyoda-Ku Tokyo, --, Japan
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Labelling Only
Reason
Update the Warning and Precautions section of the Product Monograph for drug reaction and Eosinophilia and systemic symptoms (DRESS)

Products in this notice

BrandDINStatus today
ABILIFYNot yet assigned—

Medicinal ingredients