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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215547
Company: HOPEWELL PHARMA VENTURES, INC.

Products on ANDA 215547

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLADRIBINE	CLADRIBINE	10MG	TABLET	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215547

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/04/2025	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.

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