Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761202
Company: SAMSUNG BIOEPIS CO LTD
Company: SAMSUNG BIOEPIS CO LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BYOOVIZ | RANIBIZUMAB-NUNA | 0.5MG(10MG/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 |
---|---|---|---|---|---|---|---|
09/17/2021 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761202s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761202Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761202Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/16/2023 | SUPPL-7 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761202Orig1s007Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761202Orig1s007ltr.pdf | |
10/03/2023 | SUPPL-6 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761202s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761202Orig1s006ltr.pdf | |
06/09/2022 | SUPPL-4 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761202s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761202Orig1s004ltr.pdf | |
08/15/2022 | SUPPL-3 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761202Orig1s003ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/03/2023 | SUPPL-6 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761202s006lbl.pdf | |
06/16/2023 | SUPPL-7 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761202Orig1s007Lbl.pdf | |
06/09/2022 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761202s004lbl.pdf | |
09/17/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761202s000lbl.pdf |