Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017422
Company: AVET LIFESCIENCES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BICNU CARMUSTINE 100MG/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/24/2017 SUPPL-55 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017422s055lbl.pdf
04/28/2016 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017422Orig2s050Lbl.pdf
10/18/2013 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017422s046lbl.pdf
08/11/2011 SUPPL-42 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017422s042lbl.pdf
03/14/2011 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017422s038lbl.pdf
08/17/2007 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017422s037lbl.pdf
08/17/2007 SUPPL-37 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017422s037lbl.pdf

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