NDC Code | 12948-001-01 |
Package Description | 12 TABLET, FILM COATED in 1 BOTTLE (12948-001-01) |
Product NDC | 12948-001 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Bidil |
Non-Proprietary Name | Hydralazine Hydrochloride And Isosorbide Dinitrate |
Dosage Form | TABLET, FILM COATED |
Usage | ORAL |
Start Marketing Date | 20050623 |
Marketing Category Name | NDA |
Application Number | NDA020727 |
Manufacturer | Arbor Pharmaceuticals |
Substance Name | HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE |
Strength | 37.5; 20 |
Strength Unit | mg/1; mg/1 |
Pharmacy Classes | Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] |