Approval · Notice of Compliance 1710 · 2003
TRANDATE: Notice of Compliance 1710
Issued August 1, 2003
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
- 1710
- Date
- August 1, 2003
- Company
- Shire Biochem Inc.Saint Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Manufacturer name change
- Therapeutic class
- Antihypertensive agent
Products in this notice
Medicinal ingredients
- LABETALOL HCL 5 MG per ML
- LABETALOL HCL 100 MG per TAB
- LABETALOL HCL 200 MG per TAB