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FDA approval · 2019-04-26

FDA Approved: BOSENTAN — Original Application (Actavis Pharma, Inc.)

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Summary

FDA approved a generic bosentan from Actavis Pharma under an original ANDA (ANDA207110). The approval covers its use for pulmonary arterial hypertension.

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Diseases / indications

Drugs mentioned

  • Bosentan (Bosentan)

Snippet

ORIG AP for BOSENTAN (BOSENTAN)