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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022065
Company: R-PHARM US LLC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IXEMPRA KIT IXABEPILONE 15MG/VIAL INJECTABLE;INTRAVENOUS Prescription None Yes Yes
IXEMPRA KIT IXABEPILONE 45MG/VIAL INJECTABLE;INTRAVENOUS Prescription None Yes Yes

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
01/11/2023 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022065s013lbl.pdf
01/21/2022 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022065Orig1s011lbl.pdf
10/18/2011 SUPPL-6 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022065s006lbl.pdf
05/12/2010 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022065s004s005lbl.pdf
05/12/2010 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022065s004s005lbl.pdf
10/02/2009 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022065s002lbl.pdf
10/02/2009 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022065s002lbl.pdf
03/13/2009 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022065s001lbl.pdf
03/13/2009 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022065s001lbl.pdf
10/16/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022065lbl.pdf
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