Approval · Notice of Compliance 18519 · 2016
ENTROPHEN: Notice of Compliance 18519
Issued September 23, 2016
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
- 18519
- Date
- September 23, 2016
- Product type
- Nonprescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To revise the indication, claim and safety information of the product monograph to align with the canadian reference product and to introduce a new peel-back label format
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ENTROPHEN | 02242281 | Marketed |
| ENTROPHEN 325 MG CAPLETS | 02050161 | Dormant |
| ENTROPHEN 325 MG TABLETS | 00010332 | Dormant |
| ENTROPHEN CHEWABLE | 02243974 | Marketed |
Medicinal ingredients
- ACETYLSALICYLIC ACID 81 MG per TAB
- ACETYLSALICYLIC ACID 325 MG per TAB