Product NDC: | 24338-010 |
Proprietary Name: | BiDil |
Non Proprietary Name: | Hydralazine hydrochloride and Isosorbide dinitrate |
Active Ingredient(s): | 37.5; 20 mg/1; mg/1 & nbsp; Hydralazine hydrochloride and Isosorbide dinitrate |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, FILM COATED |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 24338-010 |
Labeler Name: | Arbor Pharmaceuticals, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA020727 |
Marketing Category: | NDA |
Start Marketing Date: | 20121205 |
Package NDC: | 24338-010-18 |
Package Description: | 180 TABLET, FILM COATED in 1 BOTTLE (24338-010-18) |
NDC Code | 24338-010-18 |
Proprietary Name | BiDil |
Package Description | 180 TABLET, FILM COATED in 1 BOTTLE (24338-010-18) |
Product NDC | 24338-010 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Hydralazine hydrochloride and Isosorbide dinitrate |
Dosage Form Name | TABLET, FILM COATED |
Route Name | ORAL |
Start Marketing Date | 20121205 |
Marketing Category Name | NDA |
Labeler Name | Arbor Pharmaceuticals, Inc. |
Substance Name | HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE |
Strength Number | 37.5; 20 |
Strength Unit | mg/1; mg/1 |
Pharmaceutical Classes | Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] |