Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 205004
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BORTEZOMIB BORTEZOMIB 3.5MG/VIAL POWDER;INTRAVENOUS 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
11/06/2017 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205004s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205004Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/205004Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/20/2021 SUPPL-3 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205004s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205004Orig1s003ltr.pdf
07/12/2018 SUPPL-2 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205004s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205004Orig1s002Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/205004Orig1s002.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/20/2021 SUPPL-3 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205004s003lbl.pdf
07/12/2018 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205004s002lbl.pdf
07/12/2018 SUPPL-2 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205004s002lbl.pdf
11/06/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205004s000lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English