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

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Summary

FDA approved the original application for sodium phenylbutyrate tablets, 500 mg, by Endo USA, Inc., establishing a generic version of the drug.

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Diseases / indications

• Urea Cycle Disorders

Drugs mentioned

• Sodium phenylbutyrate tablets, 500 mg (Sodium phenylbutyrate)

Snippet

ORIG AP for SODIUM PHENYLBUTYRATE (SODIUM PHENYLBUTYRATE TABLETS, 500 MG)