Approval · Notice of Compliance 13276 · 2012
CALDOLOR: Notice of Compliance 13276
Issued May 14, 2012
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
- 13276
- Date
- May 14, 2012
- Company
- Alveda Pharmaceuticals IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of a new indication: Caldolor (ibuprofen) is indicated for the management of moderate to severe pain as an adjunct to intravenous opioid analgesics
- Therapeutic class
- Nonselective Cyclooxygenase Inhibitor; Nonsteroidal Anti-Inflammatory Drug (NSAID)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| CALDOLOR | Not yet assigned | — |
Medicinal ingredients
- IBUPROFEN 100 MG per ML