Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078340
Company: SUN PHARM
Company: SUN PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 100MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 400MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 12/03/2015 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078340Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/08/2019 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/08/2019 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/08/2019 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/08/2019 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/08/2019 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/08/2019 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |