BiDil - Hydralazine hydrochloride and Isosorbide dinitrate
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Field |
Value |
NDC Code: |
24338-010 |
Proprietary Name: |
BiDil |
Suffix: |
|
Non-Proprietary Name: |
Hydralazine hydrochloride and Isosorbide dinitrate |
Dosage Form: |
TABLET, FILM COATED |
Method: |
ORAL |
Original Marketing Date: |
05-12-2012 |
Category Name: |
NDA |
Application Number: |
NDA020727 |
Labeler: |
ARBOR PHARMACEUTICALS, 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: |
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