| Product NDC: | 0173-0847 |
| Proprietary Name: | Tafinlar |
| Non Proprietary Name: | dabrafenib |
| Active Ingredient(s): | 75 mg/1 & nbsp; dabrafenib |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0173-0847 |
| Labeler Name: | GlaxoSmithKline LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA202806 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20130610 |
| Package NDC: | 0173-0847-08 |
| Package Description: | 120 CAPSULE in 1 BOTTLE (0173-0847-08) |
| NDC Code | 0173-0847-08 |
| Proprietary Name | Tafinlar |
| Package Description | 120 CAPSULE in 1 BOTTLE (0173-0847-08) |
| Product NDC | 0173-0847 |
| 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 | 75 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes |