General MedicationsORALStandard
NISOLDIPINE
NISOLDIPINE
Standard Dose
17MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: UNKNOWN Marketing status: Prescription
Summary
Approval overview NISOLDIPINE is listed in Drugs@FDA under application 216606 (ANDA).
Review priority: UNKNOWN Marketing status: Prescription Active ingredient NISOLDIPINE Form and strength TABLET, EXTENDED RELEASE;ORAL - 17MG Sponsor AMTA Submission history Latest submission status date: 2025-12-12 00:00:00.
Structured Monograph
Clinical summary
Approval overview NISOLDIPINE is listed in Drugs@FDA under application 216606 (ANDA). Review priority: UNKNOWN Marketing status: Prescription Active ingredient NISOLDIPINE Form and strength TABLET, EXTENDED RELEASE;ORAL - 17MG Sponsor AMTA Submission history Latest submission status date: 2025-12-12 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: UNKNOWN
Interaction Notes
- No interaction notes stored yet.