APPLICATION
ANDA205077
TYPE
ANDA
ORIGINAL APPROVAL
2019-06-21
LATEST ACTION
2024-04-01
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
2024-04-01Labeling · Supplement 1 · standardAP
2024-04-01Labeling · Supplement 2 · standardAP
2019-06-21UNKNOWN · 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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