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Application 213374
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DEFERASIROX | DEFERASIROX | GRANULE;ORAL | 90MG | No | No |
| 002 | DEFERASIROX | DEFERASIROX | GRANULE;ORAL | 180MG | No | No |
| 003 | DEFERASIROX | DEFERASIROX | GRANULE;ORAL | 360MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 67877-675 | Deferasirox oral | Deferasirox oral | Ascend Laboratories, LLC | ANDA | Current |
| 67877-675 | Deferasirox oral | Deferasirox oral | Ascend Laboratories, LLC | ANDA | Current |
| 67877-675 | Deferasirox oral | Deferasirox oral | Ascend Laboratories, LLC | ANDA | Current |
| 67877-675 | Deferasirox oral | Deferasirox oral | Ascend Laboratories, LLC | ANDA | Current |
| 67877-676 | Deferasirox oral | Deferasirox oral | Ascend Laboratories, LLC | ANDA | Current |
| 67877-676 | Deferasirox oral | Deferasirox oral | Ascend Laboratories, LLC | ANDA | Current |
| 67877-676 | Deferasirox oral | Deferasirox oral | Ascend Laboratories, LLC | ANDA | Current |
| 67877-676 | Deferasirox oral | Deferasirox oral | Ascend Laboratories, LLC | ANDA | Current |
| 67877-677 | Deferasirox oral | Deferasirox oral | Ascend Laboratories, LLC | ANDA | Current |
| 67877-677 | Deferasirox oral | Deferasirox oral | Ascend Laboratories, LLC | ANDA | Current |
| 67877-677 | Deferasirox oral | Deferasirox oral | Ascend Laboratories, LLC | ANDA | Current |
| 67877-677 | Deferasirox oral | Deferasirox oral | Ascend Laboratories, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 64395 | ORIG | 2020-08-24 |