APPLICATION
ANDA215534
TYPE
ANDA
ORIGINAL APPROVAL
2022-08-23
LATEST ACTION
2025-04-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SAPROPTERIN DIHYDROCHLORIDEPrescription
SAPROPTERIN DIHYDROCHLORIDE 100MG · TABLET · ORAL
Approval history
2025-04-03Labeling · Supplement 3 · standardAP
2022-08-23UNKNOWN · Original · 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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