Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209330
Company: BRECKENRIDGE
Company: BRECKENRIDGE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARFILZOMIB | CARFILZOMIB | 10MG/VIAL | POWDER;INTRAVENOUS | Discontinued | None | No | No |
| CARFILZOMIB | CARFILZOMIB | 60MG/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 |
|---|---|---|---|---|---|---|---|
| 06/11/2021 | ORIG-2 | Tentative Approval | STANDARD |
Label is not available on this site. |
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| 06/11/2021 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209330Orig1s000ltr.pdf |