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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020873
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANGIOMAX BIVALIRUDIN 250MG/VIAL INJECTABLE;INTRAVENOUS Prescription AP Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/02/2019 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020873s039lbl.pdf
12/21/2018 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020873s037lbl.pdf
03/21/2016 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020873s036lbl.pdf
03/21/2016 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020873s036lbl.pdf
05/17/2013 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020873s029lbl.pdf
06/23/2010 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020873s023lbl.pdf
11/30/2005 SUPPL-11 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020873s011lbl.pdf
12/15/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20873lbl.pdf
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