Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761170
Company: GENENTECH INC
Company: GENENTECH INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHESGO | PERTUZUMAB;TRASTUZUMAB;HYALURONIDASE-ZZXF | 1,200MG;600MG;30,000UNITS | INJECTABLE;SUBCUTANEOUS | Prescription | None | No | No |
| PHESGO | PERTUZUMAB;TRASTUZUMAB;HYALURONIDASE-ZZXF | 600MG;600MG;20,000UNITS | INJECTABLE;SUBCUTANEOUS | 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 |
|---|---|---|---|---|---|---|---|
| 06/29/2020 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761170s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761170Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761170Orig1s000TOC.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/29/2020 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761170s000lbl.pdf |