Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208715
Company: SANDOZ
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CABAZITAXEL | CABAZITAXEL | 45MG/4.5ML (10MG/ML) | SOLUTION;INTRAVENOUS | None (Tentative Approval) | None | Yes | Yes |
CABAZITAXEL | CABAZITAXEL | 60MG/6ML (10MG/ML) | SOLUTION;INTRAVENOUS | None (Tentative Approval) | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/27/2023 | ORIG-1 | Tentative Approval | Type 3 - New Dosage Form | STANDARD |
Letter (PDF)
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Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208715Orig1s000TAltr.pdf |