Approval · Notice of Compliance 8444 · 2006
LUPRON: Notice of Compliance 8444
Issued December 7, 2006
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
- 8444
- Date
- December 7, 2006
- Company
- Tap Pharmaceuticals, Inc.Lake Forest, Illinois, United States
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Revisions to special handling instructions section as well as other sections of the product monograph
- Therapeutic class
- Gonadotropin-releasing hormone analog
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| LUPRON | Not yet assigned | — |
| LUPRON DEPOT | Not yet assigned | — |
| LUPRON DEPOT 3 MONTH SLOW RELEASE | Not yet assigned | — |
| LUPRON DEPOT 4 MONTH SLOW RELEASE | Not yet assigned | — |
Medicinal ingredients
- LEUPROLIDE ACETATE 5 MG per ML
- LEUPROLIDE ACETATE 3.75 MG per ML
- LEUPROLIDE ACETATE 7.5 MG per ML
- LEUPROLIDE ACETATE 11.25 MG per ML
- LEUPROLIDE ACETATE 15 MG per ML
- LEUPROLIDE ACETATE 22.5 MG per ML
- LEUPROLIDE ACETATE 30 MG per ML