Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 215341
Company: BAYER HLTHCARE

Products on NDA 215341

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KERENDIA	FINERENONE	10MG	TABLET;ORAL	Prescription	None	Yes	No
KERENDIA	FINERENONE	20MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 215341

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/09/2021	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215341s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215341Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215341Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/01/2022	SUPPL-1	Efficacy	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215341s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215341Orig1s001ltr.pdf

Labels for NDA 215341

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/01/2022	SUPPL-1	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215341s001lbl.pdf
07/09/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215341s000lbl.pdf