| Product NDC: | 56125-427 |
| Proprietary Name: | AMPYRA |
| Non Proprietary Name: | Dalfampridine |
| Active Ingredient(s): | 10 mg/1 & nbsp; Dalfampridine |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED, EXTENDED RELEASE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 56125-427 |
| Labeler Name: | Elan Pharma International LTD |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022250 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20100301 |
| Package NDC: | 56125-427-01 |
| Package Description: | 150000 TABLET, FILM COATED, EXTENDED RELEASE in 1 DRUM (56125-427-01) |
| NDC Code | 56125-427-01 |
| Proprietary Name | AMPYRA |
| Package Description | 150000 TABLET, FILM COATED, EXTENDED RELEASE in 1 DRUM (56125-427-01) |
| Product NDC | 56125-427 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Dalfampridine |
| Dosage Form Name | TABLET, FILM COATED, EXTENDED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20100301 |
| Marketing Category Name | NDA |
| Labeler Name | Elan Pharma International LTD |
| Substance Name | DALFAMPRIDINE |
| Strength Number | 10 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes |