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Application 020772
- Type
- BLA
- Sponsor
- QOL MEDCL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SUCRAID | SACROSIDASE | SOLUTION;ORAL | 8,500 IU/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 67871-111 | Sucraid | sacrosidase | QOL Medical, LLC | BLA | Current |
| 67871-111 | Sucraid | sacrosidase | QOL Medical, LLC | BLA | Current |
| 67871-111 | Sucraid | sacrosidase | QOL Medical, LLC | BLA | Current |
| 67871-111 | Sucraid | sacrosidase | QOL Medical, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 79331 | SUPPL | 2024-08-08 |
| 79313 | SUPPL | 2024-08-05 |
| 79232 | SUPPL | 2024-07-29 |
| 79211 | SUPPL | 2024-07-25 |
| 71160 | SUPPL | 2022-05-27 |
| 71150 | SUPPL | 2022-05-26 |
| 66401 | APPL | 2020-03-23 |
| 25767 | SUPPL | 2020-03-23 |
| 25766 | SUPPL | 2020-03-23 |
| 20930 | ORIG | 2020-03-23 |
| 3314 | SUPPL | 2020-03-23 |
| 3313 | SUPPL | 2020-03-23 |
| 3312 | ORIG | 2020-03-23 |