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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 220043
Company: HAINAN POLY PHARM

Products on ANDA 220043

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VORICONAZOLE	VORICONAZOLE	200MG/20ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 220043

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/14/2025	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/220043Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 220043

VORICONAZOLE

SOLUTION;INTRAVENOUS; 200MG/20ML (10MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VORICONAZOLE	VORICONAZOLE	200MG/20ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	220043	HAINAN POLY PHARM

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