BiDil - Hydralazine hydrochloride and Isosorbide dinitrate
Navigation: NDC > Supplier starting with: R > REMEDYREPACK INC.| Field | Value |
|---|---|
| NDC Code: | 52125-740 |
| Proprietary Name: | BiDil |
| Suffix: | |
| Non-Proprietary Name: | Hydralazine hydrochloride and Isosorbide dinitrate |
| Dosage Form: | TABLET, FILM COATED |
| Method: | ORAL |
| Original Marketing Date: | 08-10-2013 |
| Category Name: | NDA |
| Application Number: | NDA020727 |
| Labeler: | REMEDYREPACK INC. |
| Substance Name: | HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE |
| Active Numerator Strength: | 37.5; 20 |
| Active Ingredient Unit: | mg/1; mg/1 |
| Pharm Classes: | Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] |
| DEA Schedule: |