Approval · Notice of Compliance 30991 · 2023
APO-MEDROXY: Notice of Compliance 30991
Issued June 15, 2023
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
- 30991
- Date
- June 15, 2023
- Company
- Apotex Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- Addition of alternate drug substance manufacturer
- Canadian reference product
- PROVERA (Pharmacia & Upjohn Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| APO-MEDROXY; APO-MEDROXY TABLETS | Not yet assigned | — |
Medicinal ingredients
- MEDROXYPROGESTERONE ACETATE 2.5 MG per TAB
- MEDROXYPROGESTERONE ACETATE 5 MG per TAB
- MEDROXYPROGESTERONE ACETATE 10 MG per TAB
- MEDROXYPROGESTERONE ACETATE 100 MG per TAB