Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209742
Company: AMNEAL PHARMS CO
Company: AMNEAL PHARMS CO
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 |
---|---|---|---|---|---|
09/17/2024 | SUPPL-9 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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07/11/2024 | SUPPL-7 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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07/11/2024 | SUPPL-6 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
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04/29/2022 | SUPPL-5 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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11/04/2019 | SUPPL-2 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |