Application 086055
- Type
- ANDA
- Sponsor
- HIKMA INTL PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | TABLET;SUBLINGUAL | 5MG | No | No |
| 002 | ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | TABLET;SUBLINGUAL | 2.5MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0143-1767 | Isosorbide Dinitrate | Isosorbide Dinitrate | West-ward Pharmaceutical Corp | ANDA | Current |