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FDA ANDA · ANDA216266

LISDEXAMFETAMINE DIMESYLATE

lisdexamfetamine dimesylate capsules

Sponsor: PRINSTON INC

APPLICATION

ANDA216266

TYPE

ANDA

ORIGINAL APPROVAL

2023-08-25

LATEST ACTION

2024-06-04

ROUTE

ORAL

DOSAGE FORM

CAPSULE

MARKETING STATUS

Prescription

Products

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

LISDEXAMFETAMINE DIMESYLATEPrescription

LISDEXAMFETAMINE DIMESYLATE 60MG · CAPSULE · ORAL

Approval history

2024-06-04Labeling · Supplement 1 · standardAP

2023-08-25UNKNOWN · Original · standardAP

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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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