Application 205573
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ITRACONAZOLE | ITRACONAZOLE | SOLUTION;ORAL | 10MG/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 65162-087 | Itraconazole | Itraconazole | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-087 | Itraconazole | Itraconazole | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-087 | Itraconazole | Itraconazole | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-087 | Itraconazole | Itraconazole | Amneal Pharmaceuticals LL | ANDA | Current |