| NDC Code | 73141-012-03 |
|---|
| Package Description | 90 TABLET, FILM COATED in 1 BOTTLE (73141-012-03) |
|---|
| Product NDC | 73141-012 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Isosorbide Dinitrate And Hydralazine Hydrochloride |
|---|
| Non-Proprietary Name | Isosorbide Dinitrate And Hydralazine Hydrochloride |
|---|
| Dosage Form | TABLET, FILM COATED |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20240422 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA215988 |
|---|
| Manufacturer | A2A Integrated 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 [CS], Vasodilation [PE] |
|---|