Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 220747
Company: MACLEODS PHARMACEUTICALS LTD

Products on ANDA 220747

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FINERENONE	FINERENONE	10MG	TABLET; FILM COATED	None (Tentative Approval)	None	No	No
FINERENONE	FINERENONE	20MG	TABLET; FILM COATED	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 220747

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/14/2026	ORIG-1	Tentative Approval	Labeling	UNKNOWN		Label is not available on this site.