APPLICATION
ANDA203548
TYPE
ANDA
ORIGINAL APPROVAL
2015-11-23
LATEST ACTION
2024-03-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DEXTROAMPHETAMINE SULFATEPrescription
DEXTROAMPHETAMINE SULFATE 5MG · TABLET · ORAL
DEXTROAMPHETAMINE SULFATEPrescription
DEXTROAMPHETAMINE SULFATE 10MG · TABLET · ORAL
Approval history
2024-03-08Labeling · Supplement 9 · standardAP
2022-02-25Labeling · Supplement 6 · standardAP
2017-02-01Labeling · Supplement 3 · standardAP
2015-11-23UNKNOWN · 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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