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General MedicationsORALGeneric

BOSENTAN

BOSENTAN

Standard Dose
125MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued

Key Takeaways

  • Primary indication: Review priority: STANDARD Marketing status: Discontinued
  • 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 - 125MG 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 - 125MG 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.