Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 220264
Company: CHANGZHOU PHARMACEUTICAL FACTORY

Products on ANDA 220264

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VERQUVO	VERICIGUAT	5MG	TABLET	None (Tentative Approval)	None	No	No
VERQUVO	VERICIGUAT	2.5MG	TABLET	None (Tentative Approval)	None	No	No
VERQUVO	VERICIGUAT	10MG	TABLET	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 220264

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/08/2026	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.