| Product NDC: | 50419-171 |
| Proprietary Name: | Stivarga |
| Non Proprietary Name: | regorafenib |
| Active Ingredient(s): | 40 mg/1 & nbsp; regorafenib |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 50419-171 |
| Labeler Name: | Bayer HealthCare Pharmaceuticals Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA203085 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20120927 |
| Package NDC: | 50419-171-00 |
| Package Description: | 210 TABLET, FILM COATED in 1 BOX (50419-171-00) |
| NDC Code | 50419-171-00 |
| Proprietary Name | Stivarga |
| Package Description | 210 TABLET, FILM COATED in 1 BOX (50419-171-00) |
| Product NDC | 50419-171 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | regorafenib |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 20120927 |
| Marketing Category Name | NDA |
| Labeler Name | Bayer HealthCare Pharmaceuticals Inc. |
| Substance Name | REGORAFENIB MONOHYDRATE |
| Strength Number | 40 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes |