General MedicationsORALStandard
TOLVAPTAN
TOLVAPTAN
Standard Dose
30MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview TOLVAPTAN is listed in Drugs@FDA under application 218381 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient TOLVAPTAN Form and strength TABLET;ORAL - 30MG Sponsor APOTEX Submission history Latest submission status date: 2025-11-10 00:00:00.
Structured Monograph
Clinical summary
Approval overview TOLVAPTAN is listed in Drugs@FDA under application 218381 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient TOLVAPTAN Form and strength TABLET;ORAL - 30MG Sponsor APOTEX Submission history Latest submission status date: 2025-11-10 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.