FDA ANDA · ANDA214403

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE

dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate

Sponsor: LANNETT CO INC

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APPLICATION

ANDA214403

TYPE

ANDA

ORIGINAL APPROVAL

2021-11-26

LATEST ACTION

2026-10-05

ROUTE

ORAL

DOSAGE FORM

CAPSULE, EXTENDED RELEASE

MARKETING STATUS

Prescription

Products

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEPrescription

AMPHETAMINE ASPARTATE 7.5MG, AMPHETAMINE SULFATE 7.5MG, DEXTROAMPHETAMINE SACCHARATE 7.5MG, DEXTROAMPHETAMINE SULFATE 7.5MG · CAPSULE, EXTENDED RELEASE · ORAL

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEPrescription

AMPHETAMINE ASPARTATE 5MG, AMPHETAMINE SULFATE 5MG, DEXTROAMPHETAMINE SACCHARATE 5MG, DEXTROAMPHETAMINE SULFATE 5MG · CAPSULE, EXTENDED RELEASE · ORAL

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEPrescription

AMPHETAMINE ASPARTATE 2.5MG, AMPHETAMINE SULFATE 2.5MG, DEXTROAMPHETAMINE SACCHARATE 2.5MG, DEXTROAMPHETAMINE SULFATE 2.5MG · CAPSULE, EXTENDED RELEASE · ORAL

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEPrescription

AMPHETAMINE ASPARTATE 6.25MG, AMPHETAMINE SULFATE 6.25MG, DEXTROAMPHETAMINE SACCHARATE 6.25MG, DEXTROAMPHETAMINE SULFATE 6.25MG · CAPSULE, EXTENDED RELEASE · ORAL

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEPrescription

AMPHETAMINE ASPARTATE 3.75MG, AMPHETAMINE SULFATE 3.75MG, DEXTROAMPHETAMINE SACCHARATE 3.75MG, DEXTROAMPHETAMINE SULFATE 3.75MG · CAPSULE, EXTENDED RELEASE · ORAL

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEPrescription

AMPHETAMINE ASPARTATE 1.25MG, AMPHETAMINE SULFATE 1.25MG, DEXTROAMPHETAMINE SACCHARATE 1.25MG, DEXTROAMPHETAMINE SULFATE 1.25MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2026-10-05Labeling · Supplement 6 · standardAP

2026-10-05Labeling · Supplement 5 · standardAP

2024-02-27Labeling · Supplement 4 · standardAP

2023-08-24Labeling · Supplement 1 · standardAP

2021-11-26UNKNOWN · Original · standardAP

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