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FDA approval · 2025-06-09

FDA Approved: SAPROPTERIN DIHYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)

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Summary

FDA approved an original ANDA for sapropterin dihydrochloride from Aurobindo Pharma Limited.

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Diseases / indications

Drugs mentioned

  • Sapropterin dihydrochloride (Sapropterin dihydrochloride)

Snippet

ORIG AP for SAPROPTERIN DIHYDROCHLORIDE (SAPROPTERIN DIHYDROCHLORIDE)