Approval · Notice of Compliance 15412 · 2014
ZENHALE: Notice of Compliance 15412
Issued March 14, 2014
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
- 15412
- Date
- March 14, 2014
- Company
- Merck Canada IncKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of a new formoterol fumarate drug substance manufacturing site
- Therapeutic class
- Corticosteroid, long-acting beta2-agonist
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ZENHALE | Not yet assigned | — |
Medicinal ingredients
- MOMETASONE FUROATE 50 MCG per DOSE
- FORMOTEROL FUMARATE DIHYDRATE 5 MCG per DOSE
- MOMETASONE FUROATE 100 MCG per DOSE
- MOMETASONE FUROATE 200 MCG per DOSE