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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217709
Company: HAINAN POLY PHARM

Products on ANDA 217709

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
POSACONAZOLE	POSACONAZOLE	18MG	INJECTION;SOLUTION	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217709

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/09/2025	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.

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