Application 211824
- 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;ORAL | 90MG | No | No |
| 002 | DEFERASIROX | DEFERASIROX | TABLET;ORAL | 360MG | No | No |
| 003 | DEFERASIROX | DEFERASIROX | TABLET;ORAL | 180MB | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46708-410 | DEFERASIROX | DEFERASIROX | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-410 | DEFERASIROX | DEFERASIROX | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-411 | DEFERASIROX | DEFERASIROX | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-412 | DEFERASIROX | DEFERASIROX | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-412 | DEFERASIROX | DEFERASIROX | Alembic Pharmaceuticals Limited | ANDA | Current |
| 62332-410 | DEFERASIROX | DEFERASIROX | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-410 | DEFERASIROX | DEFERASIROX | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-410 | DEFERASIROX | DEFERASIROX | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-410 | DEFERASIROX | DEFERASIROX | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-410 | DEFERASIROX | DEFERASIROX | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-411 | DEFERASIROX | DEFERASIROX | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-411 | DEFERASIROX | DEFERASIROX | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-411 | DEFERASIROX | DEFERASIROX | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-411 | DEFERASIROX | DEFERASIROX | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-412 | DEFERASIROX | DEFERASIROX | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-412 | DEFERASIROX | DEFERASIROX | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-412 | DEFERASIROX | DEFERASIROX | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-412 | DEFERASIROX | DEFERASIROX | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-412 | DEFERASIROX | DEFERASIROX | Alembic Pharmaceuticals Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 61235 | ORIG | 2019-12-10 |
| 61215 | ORIG | 2019-12-10 |