Product NDC: | 66215-201 |
Proprietary Name: | Zavesca |
Non Proprietary Name: | miglustat |
Active Ingredient(s): | 100 mg/1 & nbsp; miglustat |
Administration Route(s): | ORAL |
Dosage Form(s): | CAPSULE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 66215-201 |
Labeler Name: | Actelion Pharmaceuticals US, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA021348 |
Marketing Category: | NDA |
Start Marketing Date: | 20030731 |
Package NDC: | 66215-201-90 |
Package Description: | 5 BLISTER PACK in 1 CARTON (66215-201-90) > 18 CAPSULE in 1 BLISTER PACK (66215-201-18) |
NDC Code | 66215-201-90 |
Proprietary Name | Zavesca |
Package Description | 5 BLISTER PACK in 1 CARTON (66215-201-90) > 18 CAPSULE in 1 BLISTER PACK (66215-201-18) |
Product NDC | 66215-201 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | miglustat |
Dosage Form Name | CAPSULE |
Route Name | ORAL |
Start Marketing Date | 20030731 |
Marketing Category Name | NDA |
Labeler Name | Actelion Pharmaceuticals US, Inc. |
Substance Name | MIGLUSTAT |
Strength Number | 100 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Glucosylceramide Synthase Inhibitor [EPC],Glucosylceramide Synthase Inhibitors [MoA] |