Application 211297
- Type
- ANDA
- Sponsor
- ENCUBE ETHICALS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TAVABOROLE | TAVABOROLE | SOLUTION;TOPICAL | 5% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 21922-020 | Tavaborole | TAVABOROLE topical solution, 5% | Encube Ethicals Private Limited | ANDA | Current |
| 21922-020 | Tavaborole | TAVABOROLE topical solution, 5% | Encube Ethicals Private Limited | ANDA | Current |
| 21922-020 | Tavaborole | TAVABOROLE topical solution, 5% | Encube Ethicals Private Limited | ANDA | Current |
| 21922-020 | Tavaborole | TAVABOROLE topical solution, 5% | Encube Ethicals Private Limited | ANDA | Current |
| 51862-690 | tavaborole | tavaborole | Mayne Pharma Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 64421 | ORIG | 2020-08-26 |