NDC Code | 24338-010-12 |
Package Description | 12 TABLET, FILM COATED in 1 BOTTLE (24338-010-12) |
Product NDC | 24338-010 |
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 | 20121205 |
Marketing Category Name | NDA |
Application Number | NDA020727 |
Manufacturer | Arbor Pharmaceuticals, Inc. |
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 [CS], Vasodilation [PE] |