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 |