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FDA approval · 2021-10-15

FDA Approved: ARSENIC TRIOXIDE — Original Application (Eugia US LLC)

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Summary

FDA approved a generic arsenic trioxide product (Eugia US LLC) under an original ANDA. The approval supports use for acute promyelocytic leukemia.

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Diseases / indications

Drugs mentioned

  • Arsenic Trioxide (Trisenox) (arsenic trioxide)

Snippet

ORIG AP for ARSENIC TRIOXIDE (ARSENIC TRIOXIDE)