Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208596
Company: SIGMAPHARM LABS LLC
Company: SIGMAPHARM LABS LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TICAGRELOR | TICAGRELOR | 90MG | 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 |
---|---|---|---|---|---|---|---|
04/07/2020 | ORIG-2 | Tentative Approval | STANDARD |
Label is not available on this site. |
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04/07/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |