APPLICATION
ANDA217442
TYPE
ANDA
ORIGINAL APPROVAL
2023-08-25
LATEST ACTION
2026-03-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
LISDEXAMFETAMINE DIMESYLATEPrescription
LISDEXAMFETAMINE DIMESYLATE 30MG · CAPSULE · ORAL
LISDEXAMFETAMINE DIMESYLATEPrescription
LISDEXAMFETAMINE DIMESYLATE 10MG · CAPSULE · ORAL
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
Approval history
2026-03-18Labeling · Supplement 8 · standardAP
2025-01-23Labeling · Supplement 3 · standardAP
2023-08-25UNKNOWN · 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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