APPLICATION
ANDA218016
TYPE
ANDA
ORIGINAL APPROVAL
2026-06-17
LATEST ACTION
2026-06-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SOLRIAMFETOL HYDROCHLORIDEPrescription
SOLRIAMFETOL HYDROCHLORIDE EQ 75MG BASE · TABLET · ORAL
SOLRIAMFETOL HYDROCHLORIDEPrescription
SOLRIAMFETOL HYDROCHLORIDE EQ 150MG BASE · TABLET · ORAL
Approval history
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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