Product NDC: | 66215-101 |
Proprietary Name: | Tracleer |
Non Proprietary Name: | bosentan |
Active Ingredient(s): | 62.5 mg/1 & nbsp; bosentan |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, FILM COATED |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 66215-101 |
Labeler Name: | Actelion Pharmaceuticals US, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA021290 |
Marketing Category: | NDA |
Start Marketing Date: | 20011120 |
Package NDC: | 66215-101-06 |
Package Description: | 1 BOTTLE, PLASTIC in 1 CARTON (66215-101-06) > 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC |
NDC Code | 66215-101-06 |
Proprietary Name | Tracleer |
Package Description | 1 BOTTLE, PLASTIC in 1 CARTON (66215-101-06) > 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC |
Product NDC | 66215-101 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | bosentan |
Dosage Form Name | TABLET, FILM COATED |
Route Name | ORAL |
Start Marketing Date | 20011120 |
Marketing Category Name | NDA |
Labeler Name | Actelion Pharmaceuticals US, Inc. |
Substance Name | BOSENTAN |
Strength Number | 62.5 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Endothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA] |