APPLICATION
ANDA209452
TYPE
ANDA
ORIGINAL APPROVAL
2021-03-30
LATEST ACTION
2025-01-24
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Prescription
Products
SAPROPTERIN DIHYDROCHLORIDEPrescription
SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET · FOR SOLUTION · ORAL
Approval history
2025-01-24Labeling · Supplement 8 · standardAP
2024-03-15Labeling · Supplement 6 · standardAP
2022-05-17Labeling · 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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