Product ID | 50742-246_62228a4b-3e48-471c-9e51-37bf1f44cb7b |
NDC | 50742-246 |
Product Type | Human Prescription Drug |
Proprietary Name | Isosorbide dinitrate and hydralazine hydrochloride |
Generic Name | Isosorbide Dinitrate And Hydralazine Hydrochloride |
Dosage Form | Tablet |
Route of Administration | ORAL |
Marketing Start Date | 2022-02-12 |
Marketing Category | ANDA / |
Application Number | ANDA215586 |
Labeler Name | Ingenus Pharmaceuticals, LLC |
Substance Name | HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE |
Active Ingredient Strength | 38 mg/1; mg/1 |
Pharm Classes | Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC], Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE] |
NDC Exclude Flag | N |
Listing Certified Through | 2023-12-31 |