APPLICATION
ANDA212619
TYPE
ANDA
ORIGINAL APPROVAL
2019-08-05
LATEST ACTION
2025-09-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AMPHETAMINE SULFATEPrescription
AMPHETAMINE SULFATE 5MG · TABLET · ORAL
AMPHETAMINE SULFATEPrescription
AMPHETAMINE SULFATE 10MG · TABLET · ORAL
Approval history
2025-09-26Labeling · Supplement 12 · standardAP
2023-10-17Labeling · Supplement 7 · standardAP
2022-02-25Labeling · Supplement 4 · standardAP
2022-02-10Labeling · Supplement 2 · standardAP
2019-08-05UNKNOWN · Original · 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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