FDA ANDA · ANDA216944
LISDEXAMFETAMINE DIMESYLATE
Sponsor: APOTEX
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APPLICATION
ANDA216944
TYPE
ANDA
ORIGINAL APPROVAL
2023-08-25
LATEST ACTION
2026-10-06
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
LISDEXAMFETAMINE DIMESYLATEPrescription
LISDEXAMFETAMINE DIMESYLATE 60MG · CAPSULE · ORAL
LISDEXAMFETAMINE DIMESYLATEPrescription
LISDEXAMFETAMINE DIMESYLATE 40MG · CAPSULE · ORAL
LISDEXAMFETAMINE DIMESYLATEPrescription
LISDEXAMFETAMINE DIMESYLATE 20MG · CAPSULE · ORAL
LISDEXAMFETAMINE DIMESYLATEPrescription
LISDEXAMFETAMINE DIMESYLATE 70MG · CAPSULE · ORAL
LISDEXAMFETAMINE DIMESYLATEPrescription
LISDEXAMFETAMINE DIMESYLATE 50MG · CAPSULE · ORAL
LISDEXAMFETAMINE DIMESYLATEPrescription
LISDEXAMFETAMINE DIMESYLATE 30MG · CAPSULE · ORAL
LISDEXAMFETAMINE DIMESYLATEPrescription
LISDEXAMFETAMINE DIMESYLATE 10MG · CAPSULE · ORAL
Approval history
2026-10-06Labeling · Supplement 4 · standardAP
2026-10-06Labeling · Supplement 5 · standardAP
2024-01-30Labeling · Supplement 1 · standardAP
2023-08-25UNKNOWN · Original · standardAP
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