FDA ANDA · ANDA209253
AMPHETAMINE
Sponsor: ACTAVIS LABS FL INC
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APPLICATION
ANDA209253
TYPE
ANDA
ORIGINAL APPROVAL
2023-06-22
LATEST ACTION
2026-10-19
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
AMPHETAMINEPrescription
AMPHETAMINE EQ 18.8MG BASE · TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE · ORAL
AMPHETAMINEPrescription
AMPHETAMINE EQ 12.5MG BASE · TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE · ORAL
AMPHETAMINEPrescription
AMPHETAMINE EQ 6.3MG BASE · TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE · ORAL
AMPHETAMINEPrescription
AMPHETAMINE EQ 15.7MG BASE · TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE · ORAL
AMPHETAMINEPrescription
AMPHETAMINE EQ 9.4MG BASE · TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE · ORAL
AMPHETAMINEPrescription
AMPHETAMINE EQ 3.1MG BASE · TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE · ORAL
Approval history
2026-10-19Labeling · Supplement 7 · standardAP
2025-08-08Labeling · Supplement 5 · standardAP
2025-08-08Labeling · Supplement 3 · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →