Application 208169
- Type
- NDA
- Sponsor
- WELLSTAT THERAP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | XURIDEN | URIDINE TRIACETATE | GRANULE;ORAL | 2GM/PACKET | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69468-152 | XURIDEN | uridine triacetate | Wellstat Therapeutics Corporation | NDA | Current |
| 69468-152 | XURIDEN | uridine triacetate | Wellstat Therapeutics Corporation | NDA | Current |
| 69468-152 | XURIDEN | uridine triacetate | Wellstat Therapeutics Corporation | NDA | Current |