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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205034
Company: AMNEAL PHARMS

Products on ANDA 205034

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VORICONAZOLE	VORICONAZOLE	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205034

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/13/2016	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
06/15/2022	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
06/15/2022	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
06/15/2022	SUPPL-11	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
06/15/2022	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
06/15/2022	SUPPL-7	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
06/15/2022	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
06/15/2022	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
06/15/2022	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205034

VORICONAZOLE

FOR SUSPENSION;ORAL; 200MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VFEND	VORICONAZOLE	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	Yes	AB	021630	PF PRISM CV
VORICONAZOLE	VORICONAZOLE	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	205034	AMNEAL PHARMS
VORICONAZOLE	VORICONAZOLE	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	216805	HAINAN POLY
VORICONAZOLE	VORICONAZOLE	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	206799	NOVEL LABS INC

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