Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219276
Company: HAINAN POLY PHARM. CO., LTD.

Products on ANDA 219276

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CARFILZOMIB	CARFILZOMIB	60MG/1VIAL	POWDER	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219276

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/07/2025	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.