APPLICATION
ANDA215978
TYPE
ANDA
ORIGINAL APPROVAL
2024-12-31
LATEST ACTION
2024-12-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SAFINAMIDE MESYLATEPrescription
SAFINAMIDE MESYLATE EQ 50MG BASE · TABLET · ORAL
SAFINAMIDE MESYLATEPrescription
SAFINAMIDE MESYLATE EQ 100MG BASE · TABLET · ORAL
Approval history
2024-12-31UNKNOWN · 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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