APPLICATION
ANDA083901
TYPE
ANDA
ORIGINAL APPROVAL
1984-08-31
LATEST ACTION
2023-10-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
AMPHETAMINE SULFATE · ReferenceDiscontinued
AMPHETAMINE SULFATE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
AMPHETAMINE SULFATE · ReferenceDiscontinued
AMPHETAMINE SULFATE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL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
1991-06-17Labeling · Supplement 2AP
1987-06-05Manufacturing (CMC) · Supplement 1AP
1984-08-31OriginalAP
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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