ApprovalTrail

Approval · Notice of Compliance 10706 · 2009

FLUOXETINE: Notice of Compliance 10706

Issued October 21, 2009

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
10706
Date
October 21, 2009
Company
Sandoz Canada Inc.Saint-Hubert, Quebec, Canada
Product type
Prescription Pharmaceutical
Submission
Abbreviated New Drug Submission (ANDS)
Submission class
Admin
Reason
Additional product name
Therapeutic class
Antidepressant / Antiobsessional / Antibulimic
Canadian reference product
PROZAC (Eli Lilly Canada Inc)

Products in this notice

BrandDINStatus today
FLUOXETINE02335131—
FLUOXETINE02335158—

Medicinal ingredients