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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215341

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KERENDIA (FINERENONE)
10MG
Marketing Status: Prescription
Active Ingredient: FINERENONE
Proprietary Name: KERENDIA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N215341
Product Number: 001
Approval Date: Jul 9, 2021
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
KERENDIA (FINERENONE)
20MG
Marketing Status: Prescription
Active Ingredient: FINERENONE
Proprietary Name: KERENDIA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215341
Product Number: 002
Approval Date: Jul 9, 2021
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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