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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020579
Company: SANOFI
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLOMAX TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE;ORAL Prescription AB Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/23/2019 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020579s033lbl.pdf
10/20/2014 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020579s029lbl.pdf
07/20/2014 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020579s028lbl.pdf
07/20/2014 SUPPL-28 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020579s028lbl.pdf
07/25/2011 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020579s027lbl.pdf
12/22/2009 SUPPL-26 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020579s026lbl.pdf
10/29/2009 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020579s025lbl.pdf
02/16/2007 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020579s021lbl.pdf
01/11/2007 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020579s020lbl.pdf
10/18/2005 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020579s016lbl.pdf
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