Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205573
Company: AMNEAL PHARMS

Products on ANDA 205573

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ITRACONAZOLE	ITRACONAZOLE	10MG/ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205573

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/30/2015	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
03/16/2020	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
03/16/2020	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
03/16/2020	SUPPL-2	Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205573

ITRACONAZOLE

SOLUTION;ORAL; 10MG/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ITRACONAZOLE	ITRACONAZOLE	10MG/ML	SOLUTION;ORAL	Prescription	No	AA	205573	AMNEAL PHARMS
ITRACONAZOLE	ITRACONAZOLE	10MG/ML	SOLUTION;ORAL	Prescription	No	AA	212239	ANNORA PHARMA
SPORANOX	ITRACONAZOLE	10MG/ML	SOLUTION;ORAL	Prescription	Yes	AA	020657	JANSSEN PHARMS