Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200483
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CAPECITABINE | CAPECITABINE | 150MG | TABLET;ORAL | Discontinued | None | No | No |
| CAPECITABINE | CAPECITABINE | 500MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/14/2016 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/08/2023 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/12/2022 | SUPPL-7 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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| 10/15/2021 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/2019 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/2019 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |