Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206181
Company: AJANTA PHARMA LTD

Products on ANDA 206181

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 206181

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/24/2016	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
11/29/2022	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
11/29/2022	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
06/13/2022	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
06/13/2022	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
07/16/2021	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
07/16/2021	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
07/16/2021	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
07/08/2019	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
07/08/2019	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 206181

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