| NDC Code | 71904-300-01 |
|---|
| Package Description | 4 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-01) / 1 CAPSULE in 1 BOTTLE, PLASTIC |
|---|
| Product NDC | 71904-300 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Opfolda |
|---|
| Non-Proprietary Name | Miglustat |
|---|
| Dosage Form | CAPSULE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20231011 |
|---|
| Marketing Category Name | NDA |
|---|
| Application Number | NDA215211 |
|---|
| Manufacturer | AMICUS THERAPEUTICS US, LLC |
|---|
| Substance Name | MIGLUSTAT |
|---|
| Strength | 65 |
|---|
| Strength Unit | mg/1 |
|---|
| Pharmacy Classes | Enzyme Stabilizer [EPC], Enzyme Stabilizers [MoA], Glucosylceramide Synthase Inhibitor [EPC], Glucosylceramide Synthase Inhibitors [MoA] |
|---|