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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208562
Company: XELLIA PHARMS APS

Products on NDA 208562

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VORICONAZOLE	VORICONAZOLE	200MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No
VORICONAZOLE	VORICONAZOLE	200MG	INJECTABLE;INJECTION	Prescription	None	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208562

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/09/2017	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review	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/2017/208562s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208562Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208562Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/16/2022	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208562s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208562Orig1s006ltr.pdf
01/03/2023	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208562s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208562Orig1s005ltr.pdf
12/17/2021	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208562s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208562Orig1s004ltr.pdf
03/26/2018	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208562s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208562s002ltr.pdf

Labels for NDA 208562

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/03/2023	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208562s005lbl.pdf
08/16/2022	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208562s006lbl.pdf
12/17/2021	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208562s004lbl.pdf
03/26/2018	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208562s002lbl.pdf
03/09/2017	ORIG-1	Approval	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/2017/208562s000lbl.pdf

Therapeutic Equivalents for NDA 208562

VORICONAZOLE

INJECTABLE;INTRAVENOUS; 200MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VFEND	VORICONAZOLE	200MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	Yes	AP	021267	PF PRISM CV
VORICONAZOLE	VORICONAZOLE	200MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	206398	ALMAJECT
VORICONAZOLE	VORICONAZOLE	200MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	218533	ASPIRO
VORICONAZOLE	VORICONAZOLE	200MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	211099	GLAND PHARMA LTD
VORICONAZOLE	VORICONAZOLE	200MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	214516	MEITHEAL
VORICONAZOLE	VORICONAZOLE	200MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	090862	SANDOZ INC
VORICONAZOLE	VORICONAZOLE	200MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	211661	SLATE RUN PHARMA
VORICONAZOLE	VORICONAZOLE	200MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	211264	UBI
VORICONAZOLE	VORICONAZOLE	200MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	208562	XELLIA PHARMS APS
VORICONAZOLE	VORICONAZOLE	200MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	208983	ZYDUS PHARMS

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