Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202103
Company: APOTEX
Company: APOTEX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DASATINIB | DASATINIB | 20MG | TABLET;ORAL | Discontinued | None | No | No |
| DASATINIB | DASATINIB | 50MG | TABLET;ORAL | Discontinued | None | No | No |
| DASATINIB | DASATINIB | 70MG | TABLET;ORAL | Discontinued | None | No | No |
| DASATINIB | DASATINIB | 100MG | TABLET;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/10/2016 | ORIG-1 | Approval | Not Applicable |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202103Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/202103Orig1s000BioeqR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/15/2024 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/03/2022 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/03/2022 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/03/2022 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/03/2022 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/03/2022 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/03/2022 | SUPPL-1 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |