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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209191
Company: HOSPIRA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BORTEZOMIB BORTEZOMIB 1MG/VIAL POWDER;INTRAVENOUS, SUBCUTANEOUS Prescription None Yes Yes
BORTEZOMIB BORTEZOMIB 2.5MG/VIAL POWDER;INTRAVENOUS, SUBCUTANEOUS Prescription None Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/02/2022 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209191s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209191Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/209191Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/09/2022 SUPPL-3 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209191s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209191Orig1s003ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/09/2022 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209191s003lbl.pdf
05/02/2022 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209191s000lbl.pdf
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