NDC Code | 0378-4504-05 |
Package Description | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4504-05) |
Product NDC | 0378-4504 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Dalfampridine |
Non-Proprietary Name | Dalfampridine |
Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
Usage | ORAL |
Start Marketing Date | 20220531 |
Marketing Category Name | ANDA |
Application Number | ANDA206858 |
Manufacturer | Mylan Pharmaceuticals Inc. |
Substance Name | DALFAMPRIDINE |
Strength | 10 |
Strength Unit | mg/1 |
Pharmacy Classes | Potassium Channel Antagonists [MoA], Potassium Channel Blocker [EPC] |