ApprovalTrail

Approval · Notice of Compliance 14968 · 2013

AZASITE: Notice of Compliance 14968

Issued November 20, 2013

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
14968
Date
November 20, 2013
Company
Inspire Pharmaceuticals IncLake Forest, Illinois, United States
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Change in the specification for the drug product and change in the storage recommendation for the sample size product
Therapeutic class
Macrolide antibiotic

Products in this notice

BrandDINStatus today
AZASITENot yet assigned—

Medicinal ingredients