| Product NDC: | 61958-0801 |
| Proprietary Name: | Letairis |
| Non Proprietary Name: | AMBRISENTAN |
| Active Ingredient(s): | 5 mg/1 & nbsp; AMBRISENTAN |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 61958-0801 |
| Labeler Name: | Gilead Sciences, Inc |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022081 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20070615 |
| Package NDC: | 61958-0801-3 |
| Package Description: | 1 BLISTER PACK in 1 CARTON (61958-0801-3) > 10 TABLET, FILM COATED in 1 BLISTER PACK |
| NDC Code | 61958-0801-3 |
| Proprietary Name | Letairis |
| Package Description | 1 BLISTER PACK in 1 CARTON (61958-0801-3) > 10 TABLET, FILM COATED in 1 BLISTER PACK |
| Product NDC | 61958-0801 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | AMBRISENTAN |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 20070615 |
| Marketing Category Name | NDA |
| Labeler Name | Gilead Sciences, Inc |
| Substance Name | AMBRISENTAN |
| Strength Number | 5 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Endothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA] |