Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761161
Company: CHIESI FARMACEUTICI SPA
Company: CHIESI FARMACEUTICI SPA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ELFABRIO | PEGUNIGALSIDASE ALFA-IWXJ | 20MG/10ML | VIAL; SINGLE-USE | 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 |
---|---|---|---|---|---|---|---|
05/09/2023 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761161s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761161Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761161Orig1s000TOC.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/09/2023 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761161s000lbl.pdf |