Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216757
Company: SUNSHINE LAKE PHARMA CO LTD

Products on ANDA 216757

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MIRABEGRON	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE	None (Tentative Approval)	None	No	No
MIRABEGRON	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216757

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/10/2025	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.