Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077431
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EXEMESTANE | EXEMESTANE | 25MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/01/2011 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/077431s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/07/2025 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/15/2022 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/13/2020 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/13/2020 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/06/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/06/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/03/2011 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |