Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205574
Company: ACCORD HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BENDAMUSTINE HYDROCHLORIDE BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL POWDER;IV (INFUSION) Prescription AP No No
BENDAMUSTINE HYDROCHLORIDE BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL POWDER;IV (INFUSION) Prescription AP 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
02/20/2019 ORIG-1 Tentative Approval STANDARD Label (PDF)
Letter (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205574Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205574Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205574Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/20/2019 ORIG-1 Tentative Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205574Orig1s000lbl.pdf

BENDAMUSTINE HYDROCHLORIDE

POWDER;IV (INFUSION); 25MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENDAMUSTINE HYDROCHLORIDE BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL POWDER;IV (INFUSION) Prescription No AP 205574 ACCORD HLTHCARE

POWDER;IV (INFUSION); 100MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENDAMUSTINE HYDROCHLORIDE BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL POWDER;IV (INFUSION) Prescription No AP 205574 ACCORD HLTHCARE

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