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FDA approval · 2016-06-15

FDA Approved: SODIUM PHENYLBUTYRATE — Original Application (ENDO USA, Inc.)

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Summary

FDA approved an original application for a generic sodium phenylbutyrate from ENDO USA, Inc. for the treatment of urea cycle disorders.

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Diseases / indications

Drugs mentioned

  • Sodium phenylbutyrate (sodium phenylbutyrate)

Snippet

ORIG AP for SODIUM PHENYLBUTYRATE (SODIUM PHENYLBUTYRATE)