Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210784
Company: SUN PHARM
Company: SUN PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMBRISENTAN | AMBRISENTAN | 5MG | TABLET;ORAL | Discontinued | None | No | No |
| AMBRISENTAN | AMBRISENTAN | 10MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/28/2019 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210784Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/18/2026 | SUPPL-14 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 04/04/2025 | SUPPL-13 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 08/19/2024 | SUPPL-10 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 01/18/2026 | SUPPL-9 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 06/08/2021 | SUPPL-6 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 12/22/2020 | SUPPL-4 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 11/06/2019 | SUPPL-1 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |