APPLICATION
ANDA206735
TYPE
ANDA
ORIGINAL APPROVAL
2016-01-27
LATEST ACTION
2023-10-10
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
DEXTROAMPHETAMINE SULFATEDiscontinued
DEXTROAMPHETAMINE SULFATE 10MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXTROAMPHETAMINE SULFATEDiscontinued
DEXTROAMPHETAMINE SULFATE 15MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXTROAMPHETAMINE SULFATEDiscontinued
DEXTROAMPHETAMINE SULFATE 5MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2023-10-10Labeling · Supplement 4 · standardAP
2023-10-10Labeling · Supplement 7 · standardAP
2023-10-10Labeling · Supplement 5 · standardAP
2023-10-10Labeling · Supplement 3 · standardAP
2016-01-27UNKNOWN · Original · standardAP
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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