Application 210060
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DEFERASIROX | DEFERASIROX | TABLET, FOR SUSPENSION;ORAL | 125MG | No | No |
| 002 | DEFERASIROX | DEFERASIROX | TABLET, FOR SUSPENSION;ORAL | 250MG | No | No |
| 003 | DEFERASIROX | DEFERASIROX | TABLET, FOR SUSPENSION;ORAL | 500MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46708-324 | Deferasirox | Deferasirox | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-325 | Deferasirox | Deferasirox | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-326 | Deferasirox | Deferasirox | Alembic Pharmaceuticals Limited | ANDA | Current |
| 62332-324 | Deferasirox | Deferasirox | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-324 | Deferasirox | Deferasirox | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-324 | Deferasirox | Deferasirox | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-324 | Deferasirox | Deferasirox | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-325 | Deferasirox | Deferasirox | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-325 | Deferasirox | Deferasirox | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-325 | Deferasirox | Deferasirox | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-325 | Deferasirox | Deferasirox | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-326 | Deferasirox | Deferasirox | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-326 | Deferasirox | Deferasirox | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-326 | Deferasirox | Deferasirox | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-326 | Deferasirox | Deferasirox | Alembic Pharmaceuticals Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 61212 | ORIG | 2019-12-10 |