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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090862
Company: SANDOZ INC

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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/30/2012 ORIG-1 Approval Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/090862Orig1s000Approv.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/05/2025 SUPPL-22 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.
04/28/2023 SUPPL-21 Labeling-Package Insert

Label is not available on this site.
04/28/2023 SUPPL-19 Labeling-Package Insert

Label is not available on this site.
04/28/2023 SUPPL-16 Labeling-Package Insert

Label is not available on this site.
04/28/2023 SUPPL-15 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.
06/22/2021 SUPPL-13 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
06/22/2021 SUPPL-12 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
06/22/2021 SUPPL-11 Labeling-Package Insert

Label is not available on this site.
06/22/2021 SUPPL-10 Labeling-Package Insert

Label is not available on this site.
06/22/2021 SUPPL-9 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
06/22/2021 SUPPL-8 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.
10/23/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.
10/23/2015 SUPPL-1 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

VORICONAZOLE

POWDER;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 POWDER;INTRAVENOUS Prescription Yes AP 021267 PF PRISM CV
VORICONAZOLE VORICONAZOLE 200MG/VIAL POWDER;INTRAVENOUS Prescription No AP 218533 ASPIRO
VORICONAZOLE VORICONAZOLE 200MG/VIAL POWDER;INTRAVENOUS Prescription No AP 211099 GLAND
VORICONAZOLE VORICONAZOLE 200MG/VIAL POWDER;INTRAVENOUS Prescription No AP 208562 HIKMA
VORICONAZOLE VORICONAZOLE 200MG/VIAL POWDER;INTRAVENOUS Prescription No AP 214516 MEITHEAL
VORICONAZOLE VORICONAZOLE 200MG/VIAL POWDER;INTRAVENOUS Prescription No AP 090862 SANDOZ INC
VORICONAZOLE VORICONAZOLE 200MG/VIAL POWDER;INTRAVENOUS Prescription No AP 211661 SLATE RUN PHARMA
VORICONAZOLE VORICONAZOLE 200MG/VIAL POWDER;INTRAVENOUS Prescription No AP 211264 UBI
VORICONAZOLE VORICONAZOLE 200MG/VIAL POWDER;INTRAVENOUS Prescription No AP 220078 ZHEJIANG NOVUS
VORICONAZOLE VORICONAZOLE 200MG/VIAL POWDER;INTRAVENOUS Prescription No AP 208983 ZYDUS PHARMS
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