General MedicationsORALGeneric
INSPRA
EPLERENONE
Standard Dose
100MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary
Approval overview INSPRA is listed in Drugs@FDA under application 021437 (NDA).
Review priority: STANDARD Marketing status: Discontinued Active ingredient EPLERENONE Form and strength TABLET;ORAL - 100MG Sponsor UPJOHN Submission history Latest submission status date: 2025-06-16 00:00:00.
Structured Monograph
Clinical summary
Approval overview INSPRA is listed in Drugs@FDA under application 021437 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient EPLERENONE Form and strength TABLET;ORAL - 100MG Sponsor UPJOHN Submission history Latest submission status date: 2025-06-16 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Discontinued
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.