Product NDC: | 58468-0210 |
Proprietary Name: | Aubagio |
Non Proprietary Name: | teriflunomide |
Active Ingredient(s): | 14 mg/1 & nbsp; teriflunomide |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, FILM COATED |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 58468-0210 |
Labeler Name: | Genzyme Corp. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA202992 |
Marketing Category: | NDA |
Start Marketing Date: | 20120913 |
Package NDC: | 58468-0210-1 |
Package Description: | 1 BLISTER PACK in 1 CARTON (58468-0210-1) > 5 TABLET, FILM COATED in 1 BLISTER PACK |
NDC Code | 58468-0210-1 |
Proprietary Name | Aubagio |
Package Description | 1 BLISTER PACK in 1 CARTON (58468-0210-1) > 5 TABLET, FILM COATED in 1 BLISTER PACK |
Product NDC | 58468-0210 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | teriflunomide |
Dosage Form Name | TABLET, FILM COATED |
Route Name | ORAL |
Start Marketing Date | 20120913 |
Marketing Category Name | NDA |
Labeler Name | Genzyme Corp. |
Substance Name | TERIFLUNOMIDE |
Strength Number | 14 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Pyrimidine Synthesis Inhibitor [EPC],Dihydroorotate Dehydrogenase Inhibitors [MoA] |