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Application 215723
- Type
- ANDA
- Sponsor
- RUBICON
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | TABLET;ORAL | 5MG | No | No |
| 002 | ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | TABLET;ORAL | 10MG | No | No |
| 003 | ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | TABLET;ORAL | 20MG | No | No |
| 004 | ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | TABLET;ORAL | 30MG | No | No |
| 005 | ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | TABLET;ORAL | 40MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 72888-081 | ISOSORBIDE DINITRATE | isosorbide dinitrate | Advagen Pharma Ltd | ANDA | Current |
| 72888-082 | ISOSORBIDE DINITRATE | isosorbide dinitrate | Advagen Pharma Ltd | ANDA | Current |
| 72888-083 | ISOSORBIDE DINITRATE | isosorbide dinitrate | Advagen Pharma Ltd | ANDA | Current |
| 72888-084 | ISOSORBIDE DINITRATE | isosorbide dinitrate | Advagen Pharma Ltd | ANDA | Current |
| 72888-085 | ISOSORBIDE DINITRATE | isosorbide dinitrate | Advagen Pharma Ltd | ANDA | Current |