
USFDA APPLICATION NUMBER - 12093 / DOSAGE - TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| ISOSORBIDE DINITRATE(UNII: IA7306519N) (ISOSORBIDE DINITRATE - UNII:IA7306519N) | ISOSORBIDE DINITRATE | 5mg | 40mg |
Inactive Ingredients
| Ingredient Name | BTA Pharmaceuticals, Inc. |
|---|---|
| D&C YELLOW NO. 10(35SW5USQ3G) | |
| FD&C BLUE NO. 1(H3R47K3TBD) | |
| FD&C RED NO. 40(WZB9127XOA) | |
| FD&C YELLOW NO. 6(H77VEI93A8) | |
| LACTOSE(J2B2A4N98G) | |
| MAGNESIUM STEARATE(70097M6I30) | |
| POWDERED CELLULOSE(SMD1X3XO9M) |