Application 213422
- Type
- NDA
- Sponsor
- MC2 Therapeutics Ltd
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | WYNZORA | CALCIPOTRIENE/BETAMETHASONE DIPROPIONATE | CREAM;TOPICAL | 0.005%/0.064% | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 73499-001 | Wynzora | Calcipotriene and Betamethasone dipropionate | MC2 Therapeutics Ltd | NDA | Current |
| 73499-001 | Wynzora | Calcipotriene and Betamethasone dipropionate | MC2 Therapeutics Ltd | NDA | Current |
| 73499-001 | Wynzora | Calcipotriene and Betamethasone dipropionate | MC2 Therapeutics Inc | NDA | Current |
| 73499-001 | Wynzora | Calcipotriene and Betamethasone dipropionate | MC2 Therapeutics Ltd | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 69427 | ORIG | 2021-12-01 |
| 65227 | ORIG | 2020-11-16 |
| 64005 | ORIG | 2020-07-22 |
| 63978 | ORIG | 2020-07-21 |