General MedicationsORALGeneric
BOSENTAN
BOSENTAN
Standard Dose
62.5MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary
Approval overview BOSENTAN is listed in Drugs@FDA under application 211461 (ANDA).
Review priority: STANDARD Marketing status: Discontinued Active ingredient BOSENTAN Form and strength TABLET;ORAL - 62.5MG Sponsor ALEMBIC Submission history Latest submission status date: 2020-01-23 00:00:00.
Structured Monograph
Clinical summary
Approval overview BOSENTAN is listed in Drugs@FDA under application 211461 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient BOSENTAN Form and strength TABLET;ORAL - 62.5MG Sponsor ALEMBIC Submission history Latest submission status date: 2020-01-23 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Discontinued
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.