Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206987
Company: NATCO PHARMA LTD
Company: NATCO PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BOSENTAN | BOSENTAN | 62.5MG | TABLET;ORAL | Discontinued | None | No | No |
| BOSENTAN | BOSENTAN | 125MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/26/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/03/2026 | SUPPL-11 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 11/05/2025 | SUPPL-7 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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| 02/21/2025 | SUPPL-6 | REMS-Modified, REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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| 09/17/2024 | SUPPL-5 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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| 04/29/2022 | SUPPL-4 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |