FDA Approved: SODIUM PHENYLBUTYRATE — Original Application (Zydus Pharmaceuticals USA Inc.)

View source ↗

Summary

FDA approves an original ANDA for sodium phenylbutyrate by Zydus Pharmaceuticals USA Inc., enabling a generic version of the drug.

Upgrade for the full analysis, importance score, and drug timeline.

Diseases / indications

• Hyperammonemia
• Urea Cycle Disorders

Drugs mentioned

• Sodium phenylbutyrate (sodium phenylbutyrate)

Snippet

ORIG AP for SODIUM PHENYLBUTYRATE (SODIUM PHENYLBUTYRATE)