Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761309
Company: GENENTECH INC
Company: GENENTECH INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COLUMVI | GLOFITAMAB-GXBM | 2.5MG/2.5ML(1MG/ML) | INJECTABLE;INJECTION | Prescription | None | No | No |
| COLUMVI | GLOFITAMAB-GXBM | 10MG/10ML(1MG/ML) | INJECTABLE;INJECTION | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 06/15/2023 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761309s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761309Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761309Orig1s000TOC.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/15/2023 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761309s000lbl.pdf |