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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021024
Company: SANOFI AVENTIS US

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRIFTIN RIFAPENTINE 150MG TABLET;ORAL Prescription None Yes Yes

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
06/05/2020 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021024s017s018lbl.pdf
06/05/2020 SUPPL-17 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021024s017s018lbl.pdf
06/05/2020 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021024s017s018lbl.pdf
07/01/2015 SUPPL-13 Labeling-Container/Carton Labels Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021024s013lbl.pdf
11/25/2014 SUPPL-11 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021024s011lbl.pdf
07/30/2010 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021024s009lbl.pdf
06/01/2009 SUPPL-8 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021024s008lbl.pdf
10/20/2000 SUPPL-5 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21024s5_Priftin_prntlbl.pdf
06/22/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/21024lbl.pdf
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