Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208645
Company: ACTAVIS LLC
Company: ACTAVIS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BORTEZOMIB | BORTEZOMIB | 2.5MG/ML | INJECTABLE; INJECTION | None (Tentative Approval) | None | No | No |
| BORTEZOMIB | BORTEZOMIB | 3.5MG/1.4ML | INJECTABLE; INJECTION | None (Tentative Approval) | 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 |
|---|---|---|---|---|---|---|---|
| 10/20/2016 | ORIG-1 | Tentative Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208645Orig1s000TAltr.pdf |