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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203503
Company: GLENMARK PHARMS LTD
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
09/02/2015 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/13/2022 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

06/13/2022 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

06/13/2022 SUPPL-7 Labeling-Patient Package Insert

Label is not available on this site.

06/13/2022 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

06/13/2022 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

06/28/2019 SUPPL-3 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

06/28/2019 SUPPL-2 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

06/28/2019 SUPPL-1 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 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 206762 RISING
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 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 206762 RISING
VORICONAZOLE VORICONAZOLE 200MG TABLET;ORAL Prescription No AB 200265 SANDOZ INC
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