APPLICATION
ANDA203901
TYPE
ANDA
ORIGINAL APPROVAL
2012-11-30
LATEST ACTION
2024-10-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
DEXTROAMPHETAMINE SULFATEPrescription
DEXTROAMPHETAMINE SULFATE 15MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXTROAMPHETAMINE SULFATEPrescription
DEXTROAMPHETAMINE SULFATE 5MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXTROAMPHETAMINE SULFATEPrescription
DEXTROAMPHETAMINE SULFATE 10MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2024-10-25Labeling · Supplement 16 · standardAP
2024-10-25Labeling · Supplement 20 · standardAP
2024-10-25Labeling · Supplement 17 · standardAP
2024-10-25Labeling · Supplement 13 · standardAP
2024-10-25Labeling · Supplement 11 · standardAP
2015-08-26Labeling · Supplement 8 · standardAP
2015-04-03Labeling · Supplement 4 · standardAP
2012-11-30UNKNOWN · OriginalAP
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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