Application 206741
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ITRACONAZOLE | ITRACONAZOLE | CAPSULE;ORAL | 100MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46708-204 | ITRACONAZOLE | itraconazole | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-204 | ITRACONAZOLE | itraconazole | Alembic Pharmaceuticals Limited | ANDA | Current |
| 62332-204 | ITRACONAZOLE | itraconazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-204 | ITRACONAZOLE | itraconazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-204 | ITRACONAZOLE | itraconazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-204 | ITRACONAZOLE | itraconazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-204 | ITRACONAZOLE | itraconazole | Alembic Pharmaceuticals I | ANDA | Current |
| 62332-204 | ITRACONAZOLE | itraconazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 70518-3264 | ITRACONAZOLE | itraconazole | REMEDYREPACK INC. | ANDA | Current |