APPLICATION
ANDA040361
TYPE
ANDA
ORIGINAL APPROVAL
2001-01-31
LATEST ACTION
2023-10-13
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
2023-10-13Labeling · Supplement 31 · standardAP
2023-10-13Labeling · Supplement 32 · standardAP
2022-02-25Labeling · Supplement 30 · standardAP
2017-01-04Labeling · Supplement 24 · standardAP
2015-04-17Labeling · Supplement 19 · standardAP
2015-01-29Labeling · Supplement 18 · standardAP
2008-02-06Labeling · Supplement 11AP
2007-08-31Labeling · Supplement 10AP
2002-02-14Manufacturing (CMC) · Supplement 3AP
2002-02-14Manufacturing (CMC) · Supplement 1AP
2002-02-14Manufacturing (CMC) · Supplement 4AP
2002-02-14Manufacturing (CMC) · Supplement 2AP
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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