Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021632
Company: VICURON HOLDINGS

Products on NDA 21632

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ERAXIS	ANIDULAFUNGIN	50MG/VIAL	POWDER;INTRAVENOUS	Prescription	None	Yes	Yes
ERAXIS	ANIDULAFUNGIN	100MG/VIAL	POWDER;INTRAVENOUS	Prescription	None	Yes	Yes

Labels for NDA 021632

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/05/2020	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021632s030lbl.pdf
09/22/2020	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021632027_S029lbl.pdf
09/22/2020	SUPPL-27	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021632027_S029lbl.pdf
01/05/2018	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021632s026lbl.pdf
08/17/2017	SUPPL-24	Labeling-Package Insert	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/2017/021632s024lbl.pdf
07/20/2012	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021632s011lbl.pdf
06/05/2009	SUPPL-10	Manufacturing (CMC)-Formulation	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021632s010lbl.pdf
11/09/2007	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021632s006lbl.pdf
02/02/2007	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021632s004.pdf
11/15/2006	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021632s003lbl.pdf
11/15/2006	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021632s003lbl.pdf
08/07/2006	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021632s002lbl.pdf
08/07/2006	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021632s002lbl.pdf
02/17/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021632s000,021948s000lbl.pdf