FDA Approved: GLYCEROL PHENYLBUTYRATE — Original Application (Aurobindo Pharma Limited)

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Summary

FDA approved the original ANDA for glycerol phenylbutyrate, a generic version developed by Aurobindo Pharma Limited.

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Diseases / indications

• Urea Cycle Disorders

Drugs mentioned

• Glycerol phenylbutyrate (glycerol phenylbutyrate)

Snippet

ORIG AP for GLYCEROL PHENYLBUTYRATE (GLYCEROL PHENYLBUTYRATE)