Product NDC: | 0078-0607 |
Proprietary Name: | Gilenya |
Non Proprietary Name: | Fingolimod hcl |
Active Ingredient(s): | .5 mg/1 & nbsp; Fingolimod hcl |
Administration Route(s): | ORAL |
Dosage Form(s): | CAPSULE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0078-0607 |
Labeler Name: | Novartis Pharmaceuticals Corporation |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022527 |
Marketing Category: | NDA |
Start Marketing Date: | 20100921 |
Package NDC: | 0078-0607-51 |
Package Description: | 28 CAPSULE in 1 CARTON (0078-0607-51) |
NDC Code | 0078-0607-51 |
Proprietary Name | Gilenya |
Package Description | 28 CAPSULE in 1 CARTON (0078-0607-51) |
Product NDC | 0078-0607 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Fingolimod hcl |
Dosage Form Name | CAPSULE |
Route Name | ORAL |
Start Marketing Date | 20100921 |
Marketing Category Name | NDA |
Labeler Name | Novartis Pharmaceuticals Corporation |
Substance Name | FINGOLIMOD HYDROCHLORIDE |
Strength Number | .5 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Sphingosine 1-Phosphate Receptor Modulators [MoA],Sphingosine 1-phosphate Receptor Modulator [EPC] |