Approval · Notice of Compliance 21703 · 2019
MISOPROSTOL: Notice of Compliance 21703
Issued January 2, 2019
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
- 21703
- Date
- January 2, 2019
- Company
- AA Pharma Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- Alternate manufacturing site for the active pharmaceutical ingredient. chane in manufacturing process
- Canadian reference product
- CYTOTEC (Searle Canada Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| MISOPROSTOL | Not yet assigned | — |
Medicinal ingredients
- MISOPROSTOL 100 MCG per TAB
- MISOPROSTOL 200 MCG per TAB