Approval · Notice of Compliance 10570 · 2009
LEVITRA: Notice of Compliance 10570
Issued September 1, 2009
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
- 10570
- Date
- September 1, 2009
- Company
- Bayer Inc.Elkhart, Indiana, United States
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Extension of duration of action from 4-5 hours to 8-10 hours
- Therapeutic class
- cGMP-specific phosphodiesterase type 5 inhibitor
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| LEVITRA | Not yet assigned | — |
Medicinal ingredients
- VARDENAFIL HYDROCHLORIDE 5 MG per TAB
- VARDENAFIL HYDROCHLORIDE 10 MG per TAB
- VARDENAFIL HYDROCHLORIDE 20 MG per TAB