Application 213312
- Type
- NDA
- Sponsor
- AADI BIOSCIENCE INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FYARRO | SIROLIMUS ALBUMIN-BOUND NANOPARTICLES | POWDER;INTRAVENOUS | 100MG/VIAL | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 80803-153 | FYARRO | Sirolimus | Aadi Bioscience | NDA | Current |
| 80803-153 | FYARRO | Sirolimus | Aadi Bioscience | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 71970 | ORIG | 2022-08-30 |
| 69408 | ORIG | 2021-11-24 |
| 69383 | ORIG | 2021-11-23 |