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

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Summary

FDA approves a generic sapropterin dihydrochloride product under ANDA 210027 (Original Application) by ENDO USA, Inc.

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Diseases / indications

• Phenylketonuria

Drugs mentioned

• Sapropterin dihydrochloride (Sapropterin dihydrochloride)

Snippet

ORIG AP for SAPROPTERIN DIHYDROCHLORIDE (SAPROPTERIN DIHYDROCHLORIDE)