Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 221291
Company: BAYER HEALTHCARE

Products on NDA 221291

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SUNHARBO	ASUNDEXIAN	50MG	TABLET; FILM COATED	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 221291

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/09/2026	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/221291Orig1s000ltr.pdf