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FDA ANDA · ANDA090533

DEXTROAMPHETAMINE SULFATE

Sponsor: AZURITY

APPLICATION
ANDA090533
TYPE
ANDA
ORIGINAL APPROVAL
2011-10-25
LATEST ACTION
2025-10-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

DEXTROAMPHETAMINE SULFATEPrescription
DEXTROAMPHETAMINE SULFATE 20MG · TABLET · ORAL
DEXTROAMPHETAMINE SULFATEPrescription
DEXTROAMPHETAMINE SULFATE 10MG · TABLET · ORAL
DEXTROAMPHETAMINE SULFATEPrescription
DEXTROAMPHETAMINE SULFATE 5MG · TABLET · ORAL
DEXTROAMPHETAMINE SULFATEPrescription
DEXTROAMPHETAMINE SULFATE 30MG · TABLET · ORAL
DEXTROAMPHETAMINE SULFATEPrescription
DEXTROAMPHETAMINE SULFATE 15MG · TABLET · ORAL
DEXTROAMPHETAMINE SULFATEPrescription
DEXTROAMPHETAMINE SULFATE 7.5MG · TABLET · ORAL
DEXTROAMPHETAMINE SULFATEPrescription
DEXTROAMPHETAMINE SULFATE 2.5MG · TABLET · ORAL

Approval history

2025-10-28Manufacturing (CMC) · Supplement 15 · unknown — Review ↗AP
2025-07-16Manufacturing (CMC) · Supplement 14 · unknown — Review ↗AP
2023-10-13Labeling · Supplement 12 · standardAP
2022-02-25Labeling · Supplement 11 · standardAP
2017-01-04Labeling · Supplement 7 · standardAP
2015-04-17Labeling · Supplement 5 · standardAP
2015-01-30Labeling · Supplement 4 · standardAP
2011-10-25OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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