Drugs@FDA: FDA Approved Drug Products

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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 BENDAMUSTINE 25MG/ML SOLUTION;IV (INFUSION) None (Tentative Approval) None No No
BENDAMUSTINE BENDAMUSTINE 100MG/4ML SOLUTION;IV (INFUSION) None (Tentative Approval) None No No
BENDAMUSTINE BENDAMUSTINE 200MG/8ML SOLUTION;IV (INFUSION) None (Tentative Approval) 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
01/29/2019 ORIG-1 Tentative Approval Type 5 - New Formulation or New Manufacturer STANDARD Letter (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211530Orig1s000TAltr.pdf

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