APPLICATION
ANDA214134
TYPE
ANDA
ORIGINAL APPROVAL
2023-08-25
LATEST ACTION
2024-01-05
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Prescription
Products
LISDEXAMFETAMINE DIMESYLATEPrescription
LISDEXAMFETAMINE DIMESYLATE 60MG · TABLET, CHEWABLE · ORAL
LISDEXAMFETAMINE DIMESYLATEPrescription
LISDEXAMFETAMINE DIMESYLATE 40MG · TABLET, CHEWABLE · ORAL
LISDEXAMFETAMINE DIMESYLATEPrescription
LISDEXAMFETAMINE DIMESYLATE 20MG · TABLET, CHEWABLE · ORAL
LISDEXAMFETAMINE DIMESYLATEPrescription
LISDEXAMFETAMINE DIMESYLATE 50MG · TABLET, CHEWABLE · ORAL
LISDEXAMFETAMINE DIMESYLATEPrescription
LISDEXAMFETAMINE DIMESYLATE 30MG · TABLET, CHEWABLE · ORAL
LISDEXAMFETAMINE DIMESYLATEPrescription
LISDEXAMFETAMINE DIMESYLATE 10MG · TABLET, CHEWABLE · ORAL
Approval history
2024-01-05Labeling · Supplement 1 · 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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