Product NDC: | 0173-0846 |
Proprietary Name: | Tafinlar |
Non Proprietary Name: | dabrafenib |
Active Ingredient(s): | 50 mg/1 & nbsp; dabrafenib |
Administration Route(s): | ORAL |
Dosage Form(s): | CAPSULE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0173-0846 |
Labeler Name: | GlaxoSmithKline LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA202806 |
Marketing Category: | NDA |
Start Marketing Date: | 20130610 |
Package NDC: | 0173-0846-08 |
Package Description: | 120 CAPSULE in 1 BOTTLE (0173-0846-08) |
NDC Code | 0173-0846-08 |
Proprietary Name | Tafinlar |
Package Description | 120 CAPSULE in 1 BOTTLE (0173-0846-08) |
Product NDC | 0173-0846 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | dabrafenib |
Dosage Form Name | CAPSULE |
Route Name | ORAL |
Start Marketing Date | 20130610 |
Marketing Category Name | NDA |
Labeler Name | GlaxoSmithKline LLC |
Substance Name | DABRAFENIB MESYLATE |
Strength Number | 50 |
Strength Unit | mg/1 |
Pharmaceutical Classes |