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: | 50419-171-03 |
Package Description: | 3 BOTTLE, PLASTIC in 1 BOX (50419-171-03) > 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-171-01) |
NDC Code | 50419-171-03 |
Proprietary Name | Stivarga |
Package Description | 3 BOTTLE, PLASTIC in 1 BOX (50419-171-03) > 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-171-01) |
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 |