APPLICATION
ANDA200166
TYPE
ANDA
ORIGINAL APPROVAL
2012-08-09
LATEST ACTION
2023-10-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
EVEKEOPrescription
AMPHETAMINE SULFATE 10MG · TABLET · ORAL
EVEKEOPrescription
AMPHETAMINE SULFATE 5MG · TABLET · ORAL
Approval history
2023-10-13Labeling · Supplement 10 · standardAP
2022-02-25Labeling · Supplement 9 · standardAP
2017-01-04Labeling · Supplement 5 · standardAP
2015-04-17Labeling · Supplement 3 · standardAP
2014-09-12Labeling · Supplement 2 · standardAP
2012-08-09Not Applicable · 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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