Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090547
Company: MYLAN PHARMS INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VORICONAZOLE VORICONAZOLE 50MG TABLET;ORAL Prescription AB No No
VORICONAZOLE VORICONAZOLE 200MG TABLET;ORAL Prescription AB 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
04/22/2010 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090547s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/12/2016 SUPPL-6 Labeling-Package Insert

Label is not available on this site.
01/12/2016 SUPPL-5 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
03/27/2013 SUPPL-2 Labeling-Package Insert

Label is not available on this site.
03/09/2011 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

VORICONAZOLE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
VFEND VORICONAZOLE 50MG TABLET;ORAL Prescription Yes AB 021266 PF PRISM CV
VORICONAZOLE VORICONAZOLE 50MG TABLET;ORAL Prescription No AB 206181 AJANTA PHARMA LTD
VORICONAZOLE VORICONAZOLE 50MG TABLET;ORAL Prescription No AB 207049 AKORN
VORICONAZOLE VORICONAZOLE 50MG TABLET;ORAL Prescription No AB 206762 APPCO
VORICONAZOLE VORICONAZOLE 50MG TABLET;ORAL Prescription No AB 206837 AUROBINDO PHARMA LTD
VORICONAZOLE VORICONAZOLE 50MG TABLET;ORAL Prescription No AB 206747 CADILA
VORICONAZOLE VORICONAZOLE 50MG TABLET;ORAL Prescription No AB 203503 GLENMARK PHARMS LTD
VORICONAZOLE VORICONAZOLE 50MG TABLET;ORAL Prescription No AB 090547 MYLAN PHARMS INC
VORICONAZOLE VORICONAZOLE 50MG TABLET;ORAL Prescription No AB 207371 NOVEL LABS INC
VORICONAZOLE VORICONAZOLE 50MG TABLET;ORAL Prescription No AB 206654 PRINSTON INC
VORICONAZOLE VORICONAZOLE 50MG TABLET;ORAL Prescription No AB 200265 SANDOZ INC

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
VFEND VORICONAZOLE 200MG TABLET;ORAL Prescription Yes AB 021266 PF PRISM CV
VORICONAZOLE VORICONAZOLE 200MG TABLET;ORAL Prescription No AB 206181 AJANTA PHARMA LTD
VORICONAZOLE VORICONAZOLE 200MG TABLET;ORAL Prescription No AB 207049 AKORN
VORICONAZOLE VORICONAZOLE 200MG TABLET;ORAL Prescription No AB 206762 APPCO
VORICONAZOLE VORICONAZOLE 200MG TABLET;ORAL Prescription No AB 206837 AUROBINDO PHARMA LTD
VORICONAZOLE VORICONAZOLE 200MG TABLET;ORAL Prescription No AB 206747 CADILA
VORICONAZOLE VORICONAZOLE 200MG TABLET;ORAL Prescription No AB 203503 GLENMARK PHARMS LTD
VORICONAZOLE VORICONAZOLE 200MG TABLET;ORAL Prescription No AB 090547 MYLAN PHARMS INC
VORICONAZOLE VORICONAZOLE 200MG TABLET;ORAL Prescription No AB 207371 NOVEL LABS INC
VORICONAZOLE VORICONAZOLE 200MG TABLET;ORAL Prescription No AB 206654 PRINSTON INC
VORICONAZOLE VORICONAZOLE 200MG TABLET;ORAL Prescription No AB 200265 SANDOZ INC

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