Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205722
Company: XELLIA PHARMS APS
Company: XELLIA PHARMS APS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TIGECYCLINE | TIGECYCLINE | 50MG/VIAL | POWDER;INTRAVENOUS | 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 |
---|---|---|---|---|---|---|---|
10/18/2019 | 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 |
---|---|---|---|---|---|
11/28/2023 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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11/28/2023 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |