Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021673
Company: GENZYME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOLAR CLOFARABINE 20MG/20ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription AP Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/20/2019 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021673s026lbl.pdf
10/27/2016 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021673s025lbl.pdf
12/16/2015 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021673s024lbl.pdf
09/15/2014 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021673s023lbl.pdf
01/10/2013 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021673s022lbl.pdf
06/10/2011 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021673s010lbledt.pdf
12/28/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021673lbl.pdf

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