APPLICATION
ANDA040776
TYPE
ANDA
ORIGINAL APPROVAL
2008-01-29
LATEST ACTION
2023-10-13
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
DEXTROAMPHETAMINE SULFATEPrescription
DEXTROAMPHETAMINE SULFATE 5MG/5ML · SOLUTION · ORAL
Approval history
2023-10-13Labeling · Supplement 7 · standardAP
2022-02-25Labeling · Supplement 6 · standardAP
2017-01-04Labeling · Supplement 4 · standardAP
2016-12-27Labeling · Supplement 3 · standardAP
2015-04-17Labeling · Supplement 2 · 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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