← FDA DRUG APPROVALS

FDA ANDA · ANDA209253

AMPHETAMINE

Sponsor: ACTAVIS LABS FL INC

APPLICATION
ANDA209253
TYPE
ANDA
ORIGINAL APPROVAL
2023-06-22
LATEST ACTION
2025-08-08
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

2025-08-08Labeling · Supplement 5 · standardAP
2025-08-08Labeling · Supplement 3 · standardAP
2023-06-22UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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