Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761313
Company: HALOZYME THERAP
Company: HALOZYME THERAP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| Hyaluronidase human recombinant for further manufacturing use | Hyaluronidase human recombinant for further manufacturing use | 10MG/ML | INJECTABLE;INJECTION | For Further Manufacturing Use | N/A | N/A | N/A |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/20/2023 | ORIG-1 | Approval | N/A |
Letter (PDF)
Summary Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761313Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2024/761313Orig1s000SumR.pdf |