FDA Approval for ZALTRAP issued to SANOFI AVENTIS US
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Biotechnology: Pharmaceutical Preparations
Health Care
Biologic License Application (BLA): 125418
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZALTRAP | ZIV-AFLIBERCEPT | 4MG | 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 |
|---|---|---|---|---|---|---|---|
| 08/03/2012 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125418s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125418Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125418_zaltrap_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125418Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/13/2023 | SUPPL-54 | Supplement |
Label is not available on this site. |
||
| 06/05/2020 | SUPPL-47 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125418s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125418Orig1s047ltr.pdf | |
| 03/11/2020 | SUPPL-46 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125418s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125418Orig1s046ltr.pdf | |
| 11/25/2019 | SUPPL-45 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125418s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125418Orig1s045ltr.pdf | |
| 06/24/2016 | SUPPL-39 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125418s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125418Orig1s039ltr.pdf | |
| 03/09/2016 | SUPPL-37 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125418s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125418Orig1s037ltr.pdf | |
| 09/17/2015 | SUPPL-33 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125418Orig1s033ltr.pdf |
| 10/25/2013 | SUPPL-20 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125418s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125418Orig1s020ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/05/2020 | SUPPL-47 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125418s047lbl.pdf | |
| 03/11/2020 | SUPPL-46 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125418s046lbl.pdf | |
| 11/25/2019 | SUPPL-45 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125418s045lbl.pdf | |
| 06/24/2016 | SUPPL-39 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125418s039lbl.pdf | |
| 03/09/2016 | SUPPL-37 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125418s037lbl.pdf | |
| 10/25/2013 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125418s020lbl.pdf | |
| 08/03/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125418s000lbl.pdf |