APPLICATION
ANDA202835
TYPE
ANDA
ORIGINAL APPROVAL
2023-08-25
LATEST ACTION
2023-08-25
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
2023-08-25UNKNOWN · OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.