FDA Approval for UDENYCA issued to COHERUS BIOSCIENCES INC
$CHRS
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
Biologic License Application (BLA): 761039
Company: COHERUS BIOSCIENCES INC
Company: COHERUS BIOSCIENCES INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| UDENYCA | PEGFILGRASTIM-CBQV | 6MG/0.6ML | 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 |
|---|---|---|---|---|---|---|---|
| 11/02/2018 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761039s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761039Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761039Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-15 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761039s015lbl.pdf | |
| 11/28/2022 | SUPPL-14 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761039s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761039Orig1s014ltr.pdf | |
| 03/03/2023 | SUPPL-13 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761039s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761039Orig1s013ltr.pdf | |
| 06/07/2021 | SUPPL-10 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761039s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761039Orig1s010ltr.pdf | |
| 10/17/2019 | SUPPL-4 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761039Orig1s004ltr.pdf |
| 02/12/2020 | SUPPL-3 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761039s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761039Orig1s003ltr.pdf | |
| 04/16/2019 | SUPPL-1 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761039s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761039Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-15 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761039s015lbl.pdf | |
| 03/03/2023 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761039s013lbl.pdf | |
| 11/28/2022 | SUPPL-14 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761039s014lbl.pdf | |
| 06/07/2021 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761039s010lbl.pdf | |
| 06/07/2021 | SUPPL-10 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761039s010lbl.pdf | |
| 02/12/2020 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761039s003lbl.pdf | |
| 02/12/2020 | SUPPL-3 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761039s003lbl.pdf | |
| 02/12/2020 | SUPPL-3 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761039s003lbl.pdf | |
| 04/16/2019 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761039s001lbl.pdf | |
| 11/02/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761039s000lbl.pdf |