Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211224
Company: ZYDUS
Company: ZYDUS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MACITENTAN | MACITENTAN | 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 |
|---|---|---|---|---|---|---|---|
| 04/06/2021 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211224Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/11/2024 | SUPPL-2 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 02/01/2023 | SUPPL-1 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |