FDA ANDA · ANDA205401
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
Sponsor: ANI PHARMS
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APPLICATION
ANDA205401
TYPE
ANDA
ORIGINAL APPROVAL
2019-01-22
LATEST ACTION
2026-10-14
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
2026-10-14Labeling · Supplement 14 · standardAP
2026-10-14Labeling · Supplement 19 · standardAP
2024-03-28Labeling · Supplement 8 · standardAP
2023-03-03Labeling · Supplement 6 · standardAP
2023-03-03Labeling · Supplement 2 · standardAP
2019-01-22UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →