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Drugs@FDA: FDA-Approved Drugs

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

Products on NDA 022065

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022065

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
01/11/2023	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022065s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022065orig1s013ltr.pdf
01/21/2022	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022065Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022065Orig1s011ltr.pdf
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

Labels for NDA 022065

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-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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