Drugs@FDA: FDA-Approved Drugs

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

Products on ANDA 090547

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090547

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
09/11/2023	SUPPL-18	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
09/11/2023	SUPPL-16	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
09/11/2023	SUPPL-15	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/11/2023	SUPPL-13	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/11/2023	SUPPL-12	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/11/2023	SUPPL-11	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
09/11/2023	SUPPL-10	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
09/11/2023	SUPPL-9	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/11/2023	SUPPL-8	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 090547

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	206837	AUROBINDO PHARMA LTD
VORICONAZOLE	VORICONAZOLE	50MG	TABLET;ORAL	Prescription	No	AB	206747	CADILA
VORICONAZOLE	VORICONAZOLE	50MG	TABLET;ORAL	Prescription	No	AB	207371	CHARTWELL RX
VORICONAZOLE	VORICONAZOLE	50MG	TABLET;ORAL	Prescription	No	AB	207049	EPIC PHARMA LLC
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	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	206837	AUROBINDO PHARMA LTD
VORICONAZOLE	VORICONAZOLE	200MG	TABLET;ORAL	Prescription	No	AB	206747	CADILA
VORICONAZOLE	VORICONAZOLE	200MG	TABLET;ORAL	Prescription	No	AB	207371	CHARTWELL RX
VORICONAZOLE	VORICONAZOLE	200MG	TABLET;ORAL	Prescription	No	AB	207049	EPIC PHARMA LLC
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	206654	PRINSTON INC
VORICONAZOLE	VORICONAZOLE	200MG	TABLET;ORAL	Prescription	No	AB	206762	RISING
VORICONAZOLE	VORICONAZOLE	200MG	TABLET;ORAL	Prescription	No	AB	200265	SANDOZ INC