Approval · Notice of Compliance 21419 · 2018
PROTOPIC: Notice of Compliance 21419
Issued October 12, 2018
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
- 21419
- Date
- October 12, 2018
- Company
- Leo Pharma IncToronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of a second manufacturer of tacrolimus, concord biotech ltd, india
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PROTOPIC | Not yet assigned | — |
Medicinal ingredients
- TACROLIMUS 0.03 PER
- TACROLIMUS 0.1 MG per G