APPLICATION
ANDA207685
TYPE
ANDA
ORIGINAL APPROVAL
2021-06-15
LATEST ACTION
2025-02-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SAPROPTERIN DIHYDROCHLORIDEPrescription
SAPROPTERIN DIHYDROCHLORIDE 100MG · TABLET · ORAL
Approval history
2025-02-28Labeling · Supplement 6 · standardAP
2022-05-26Labeling · Supplement 1 · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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