Approval · Notice of Compliance 25432 · 2021
ONDISSOLVE ODF: Notice of Compliance 25432
Issued March 15, 2021
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
- 25432
- Date
- March 15, 2021
- Company
- Takeda Canada IncorporatedToronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- Addition of an alternate drug substance manufacturing site
- Canadian reference product
- ZOFRAN ZYDIS LINGUAL (Glaxosmithkline Inc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ONDISSOLVE ODF | Not yet assigned | — |
Medicinal ingredients
- ONDANSETRON 4 MG per PIECE
- ONDANSETRON 8 MG per PIECE