Approval · Notice of Compliance 15730 · 2014
NIKKI: Notice of Compliance 15730
Issued June 17, 2014
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
- 15730
- Date
- June 17, 2014
- Company
- Lupin LimitedMumbai, Maharashtra, India
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Other
- Therapeutic class
- Oral contraceptive; acne therapy
- Canadian reference product
- YAZ (Bayer Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| NIKKI | 02416492 | Approved |
Medicinal ingredients
- ETHINYL ESTRADIOL 0.02 MG per TAB
- DROSPIRENONE 3 MG per TAB