Aubagio is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Genzyme Corporation. The primary component is Teriflunomide.
Product ID | 58468-0211_00ccc1a2-a63c-418a-9f40-1792b505f2c8 |
NDC | 58468-0211 |
Product Type | Human Prescription Drug |
Proprietary Name | Aubagio |
Generic Name | Teriflunomide |
Dosage Form | Tablet, Film Coated |
Route of Administration | ORAL |
Marketing Start Date | 2013-05-01 |
Marketing Category | NDA / NDA |
Application Number | NDA202992 |
Labeler Name | Genzyme Corporation |
Substance Name | TERIFLUNOMIDE |
Active Ingredient Strength | 7 mg/1 |
Pharm Classes | Pyrimidine Synthesis Inhibitor [EPC],Dihydroorotate Dehydrogenase Inhibitors [MoA] |
NDC Exclude Flag | N |
Listing Certified Through | 2021-12-31 |
Marketing Start Date | 2013-05-01 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA202992 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2013-05-01 |
Marketing Category | NDA |
Application Number | NDA202992 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2013-05-01 |
Marketing Category | NDA |
Application Number | NDA202992 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2019-03-28 |
Marketing Category | NDA |
Application Number | NDA202992 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2013-05-01 |
NDC | Brand Name | Generic Name |
---|---|---|
58468-0210 | Aubagio | teriflunomide |
58468-0211 | Aubagio | teriflunomide |
0115-1565 | Teriflunomide | Teriflunomide |
68462-311 | teriflunomide | teriflunomide |
68462-312 | teriflunomide | teriflunomide |
69238-1303 | Teriflunomide | Teriflunomide |
69238-1304 | Teriflunomide | Teriflunomide |
69539-032 | Teriflunomide | Teriflunomide |
69539-033 | Teriflunomide | Teriflunomide |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AUBAGIO 85265807 4048507 Live/Registered |
SANOFI 2011-03-14 |
AUBAGIO 79137227 4553962 Live/Registered |
SANOFI 2013-08-26 |