FDA ANDA · ANDA218725
SOLRIAMFETOL
Sponsor: AUROBINDO PHARMA LTD
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APPLICATION
ANDA218725
TYPE
ANDA
ORIGINAL APPROVAL
2026-10-06
LATEST ACTION
2026-10-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval), Prescription
Products
SOLRIAMFETOLNone (Tentative Approval)
SOLRIAMFETOL 150MG · TABLET
SOLRIAMFETOL HYDROCHLORIDEPrescription
SOLRIAMFETOL HYDROCHLORIDE EQ 75MG BASE · TABLET · ORAL
SOLRIAMFETOL HYDROCHLORIDEPrescription
SOLRIAMFETOL HYDROCHLORIDE EQ 150MG BASE · TABLET · ORAL
Approval history
2026-10-06UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →