Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206398
Company: ALMAJECT

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
03/23/2016 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
07/02/2021 SUPPL-5 Labeling-Patient Package Insert

Label is not available on this site.
07/02/2021 SUPPL-1 Labeling-Patient Package Insert, Labeling-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 ALMAJECT
VORICONAZOLE VORICONAZOLE 200MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 211099 GLAND PHARMA LTD
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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