Drugs@FDA: FDA Approved Drug Products

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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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/16/2007 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022065s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022065TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/22/2016 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/26/2016 SUPPL-9 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

01/20/2015 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/18/2011 SUPPL-6 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022065s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022065s006ltr.pdf
05/12/2010 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022065s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022065s004,s005ltr.pdf
05/12/2010 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022065s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022065s004,s005ltr.pdf
10/02/2009 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022065s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022065s002,s003ltr.pdf
10/02/2009 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022065s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022065s002,s003ltr.pdf
03/13/2009 SUPPL-1 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022065s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022065s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022065s001lbl.pdf
03/13/2009 SUPPL-1 Labeling-Container/Carton Labels 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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