APPLICATION
ANDA206588
TYPE
ANDA
ORIGINAL APPROVAL
2016-03-28
LATEST ACTION
2022-02-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DEXTROAMPHETAMINE SULFATEDiscontinued
DEXTROAMPHETAMINE SULFATE 10MG · TABLET · ORAL
DEXTROAMPHETAMINE SULFATEDiscontinued
DEXTROAMPHETAMINE SULFATE 5MG · TABLET · ORAL
Approval history
2022-02-25Labeling · Supplement 4 · standardAP
2017-02-09Labeling · Supplement 2 · standardAP
2016-03-28UNKNOWN · 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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