FDA ANDA · ANDA218832
PITOLISANT HYDROCHLORIDE
Sponsor: ANNORA PHARMA
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APPLICATION
ANDA218832
TYPE
ANDA
ORIGINAL APPROVAL
2026-10-08
LATEST ACTION
2026-10-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PITOLISANT HYDROCHLORIDEPrescription
PITOLISANT HYDROCHLORIDE EQ 17.8MG BASE · TABLET · ORAL
PITOLISANT HYDROCHLORIDEPrescription
PITOLISANT HYDROCHLORIDE EQ 4.45MG BASE · TABLET · ORAL
Approval history
2026-10-08UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →