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FDA approval · 2019-05-10

FDA Approved: SAPROPTERIN DIHYDROCHLORIDE — Original Application (ENDO USA, Inc.)

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Summary

The FDA approved the Original Application for sapropterin dihydrochloride from ENDO USA, Inc., authorizing a generic version of the drug.

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Diseases / indications

Drugs mentioned

  • Sapropterin dihydrochloride (Sapropterin dihydrochloride)

Snippet

ORIG AP for SAPROPTERIN DIHYDROCHLORIDE (SAPROPTERIN DIHYDROCHLORIDE)