APPLICATION
ANDA085652
TYPE
ANDA
ORIGINAL APPROVAL
1980-06-20
LATEST ACTION
2023-10-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DEXTROAMPHETAMINE SULFATEDiscontinued
DEXTROAMPHETAMINE SULFATE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2023-10-13Labeling · Supplement 7 · standardAP
2022-02-25Labeling · Supplement 6 · standardAP
2017-01-04Labeling · Supplement 4 · standardAP
2015-04-17Labeling · Supplement 3 · standardAP
1991-02-11Labeling · Supplement 2AP
1988-08-10Labeling · Supplement 1AP
1980-06-20OriginalAP
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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