Drugs@FDA: FDA Approved Drug Products

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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 INJECTABLE;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
10/23/2015 SUPPL-2 Labeling-Package Insert

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

Label is not available on this site.

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 ALVOGEN
VORICONAZOLE VORICONAZOLE 200MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 211661 HAINAN POLY PHARM
VORICONAZOLE VORICONAZOLE 200MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 090862 SANDOZ INC
VORICONAZOLE VORICONAZOLE 200MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 208983 ZYDUS PHARMS

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