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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211530
Company: HOSPIRA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BENDAMUSTINE HYDROCHLORIDE BENDAMUSTINE HYDROCHLORIDE 25MG/ML (25MG/ML) SOLUTION;INTRAVENOUS Discontinued None Yes No
BENDAMUSTINE HYDROCHLORIDE BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION;INTRAVENOUS Discontinued None Yes No
BENDAMUSTINE HYDROCHLORIDE BENDAMUSTINE HYDROCHLORIDE 200MG/8ML (25MG/ML) SOLUTION;INTRAVENOUS Discontinued None Yes 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
12/15/2022 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211530s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211530Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/211530Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/25/2024 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211530s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/211530Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
01/25/2024 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211530s001lbl.pdf
12/15/2022 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211530s000lbl.pdf
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