General MedicationsORALStandard
BOSENTAN
BOSENTAN
Standard Dose
32MG
Max Dose
Refer to approved labeling
Primary Use
Marketing status: Prescription
Summary
Approval overview BOSENTAN is listed in Drugs@FDA under application 213981 (ANDA).
Marketing status: Prescription Active ingredient BOSENTAN Form and strength TABLET, FOR SUSPENSION;ORAL - 32MG Sponsor ZYDUS PHARMS Submission history Latest submission status date: 2026-03-03 00:00:00.
Structured Monograph
Clinical summary
Approval overview BOSENTAN is listed in Drugs@FDA under application 213981 (ANDA). Marketing status: Prescription Active ingredient BOSENTAN Form and strength TABLET, FOR SUSPENSION;ORAL - 32MG Sponsor ZYDUS PHARMS Submission history Latest submission status date: 2026-03-03 00:00:00. Submission type: SUPPL.
Monitoring
- • Review priority: N/A
- • Marketing status: Prescription
Interaction Notes
- No interaction notes stored yet.