Application 208623
- Type
- NDA
- Sponsor
- AMICUS THERAPS US
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GALAFOLD | MIGALASTAT HYDROCHLORIDE | CAPSULE;ORAL | EQ 123MG BASE | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 71904-100 | Galafold | migalastat hydrochloride | Amicus Therapeutics U.S., Inc. | NDA | Current |
| 71904-100 | Galafold | migalastat hydrochloride | Amicus Therapeutics U.S., Inc. | NDA | Current |
| 71904-100 | Galafold | migalastat hydrochloride | Amicus Therapeutics US, LLC | NDA | Current |
| 71904-100 | Galafold | migalastat hydrochloride | Amicus Therapeutics US, LLC | NDA | Current |
| 71904-100 | Galafold | migalastat hydrochloride | Amicus Therapeutics U.S., Inc. | NDA | Current |
| 71904-100 | Galafold | migalastat hydrochloride | Amicus Therapeutics U.S., Inc. | NDA | Current |
| 71904-100 | Galafold | migalastat hydrochloride | Amicus Therapeutics US, LLC | NDA | Current |
| 71904-100 | Galafold | migalastat hydrochloride | Amicus Therapeutics U.S., Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 81687 | SUPPL | 2025-03-24 |
| 81655 | SUPPL | 2025-03-20 |
| 78724 | SUPPL | 2024-07-02 |
| 78698 | SUPPL | 2024-06-06 |
| 74604 | SUPPL | 2023-06-22 |
| 74603 | SUPPL | 2023-06-22 |
| 74580 | SUPPL | 2023-06-21 |
| 74579 | SUPPL | 2023-06-21 |
| 69556 | SUPPL | 2021-12-15 |
| 69551 | SUPPL | 2021-12-14 |
| 64749 | SUPPL | 2020-09-29 |
| 64737 | SUPPL | 2020-09-29 |
| 59827 | SUPPL | 2019-08-23 |
| 59826 | SUPPL | 2019-08-23 |
| 55432 | ORIG | 2018-09-11 |
| 55172 | ORIG | 2018-08-14 |
| 55165 | ORIG | 2018-08-10 |