Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761328
Company: ASTRAZENECA AB
Company: ASTRAZENECA AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BEYFORTUS | NIRSEVIMAB-ALIP | 50MG | INJECTABLE;INJECTION | Prescription | None | No | No |
BEYFORTUS | NIRSEVIMAB-ALIP | 100MG | 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 |
---|---|---|---|---|---|---|---|
07/17/2023 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761328s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761328Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761328Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/23/2024 | SUPPL-7 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761328s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761328Orig1s007ltr.pdf | |
08/22/2024 | SUPPL-5 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761328s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761328Orig1s005ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/22/2024 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761328s005lbl.pdf | |
02/23/2024 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761328s007lbl.pdf | |
07/17/2023 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761328s000lbl.pdf |