Application 018689
- Type
- NDA
- Sponsor
- SEBELA IRELAND LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RIDAURA | AURANOFIN | CAPSULE;ORAL | 3MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 54766-093 | RIDAURA | auranofin | Sebela Pharmaceuticals Inc. | NDA | Current |
| 65483-093 | RIDAURA | auranofin | Prometheus Laboratories Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 57617 | ORIG | 2019-02-15 |