Xtandi
enzalutamide
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3022131441 | 3022131441 | ASTEL.INC | 1 | N | 2026-01-01 | Gajeongbuk-ro 26-79 Yuseong-gu Daejeon KR 34113 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00304692416089 | DIGITIVA Mobile Application - Software as a Medical Device (SaMD) which operates as a medication reminder and support services; Operates on Apple iOS devices. | 8553486069 | DIGITIVA-support@astellas.com |
| 00304692416447 | DIGITIVA Mobile Application - Software as a Medical Device (SaMD) which operates as a medication reminder and support services; Operates on Android devices. | 8553486069 | DIGITIVA-support@astellas.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 303868 | 1493264688 | K212051 | RFA-1717DIG, RFA-1717DIC | MQB | 2021-08-25 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| MQB | 1 | 2021-08-25 |
enzalutamide
isavuconazonium sulfate
isavuconazonium sulfate
Tacrolimus
Tacrolimus
enzalutamide
tacrolimus extended-release capsules
Tacrolimus
tacrolimus extended-release capsules
tacrolimus extended-release capsules
enzalutamide
enzalutamide
Tacrolimus
Tacrolimus
gilteritinib
enzalutamide
fezolinetant
mirabegron
mirabegron
fezolinetant
fezolinetant
isavuconazonium sulfate
Tacrolimus
amphotericin B
Micafungin sodium
ZOLBETUXIMAB
ZOLBETUXIMAB
mirabegron
regadenoson
solifenacin succinate
solifenacin succinate
solifenacin succinate
avacincaptad pegol
ASTEL Inc.
Astell Scientific Limited
2024-12-12
2025-01-10