Approval · Notice of Compliance 17082 · 2015
ACULAR: Notice of Compliance 17082
Issued July 14, 2015
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
- 17082
- Date
- July 14, 2015
- Company
- Allergan IncMarkham, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To revise the pediatric statement to indicate that the safety and effectivemess of acular/acular ls has not been established in pediatric patients
- Therapeutic class
- Non-steroidal anti-inflammatory agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ACULAR | Not yet assigned | — |
| ACULAR LS | Not yet assigned | — |
Medicinal ingredients
- KETOROLAC TROMETHAMINE 5 MG per ML
- KETOROLAC TROMETHAMINE 4 MG per ML