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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211099
Company: GLAND PHARMA LTD

Products on ANDA 211099

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VORICONAZOLE	VORICONAZOLE	200MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211099

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/31/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2022	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
12/13/2022	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
06/06/2022	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
06/06/2022	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
06/06/2022	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
06/06/2022	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
06/06/2022	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 211099

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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