← FDA DRUG APPROVALS
FDA ANDA · ANDA040444
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
Sponsor: EPIC PHARMA LLC
APPLICATION
ANDA040444
TYPE
ANDA
ORIGINAL APPROVAL
2002-06-19
LATEST ACTION
2023-10-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEPrescription
AMPHETAMINE ASPARTATE 3.125MG, AMPHETAMINE SULFATE 3.125MG, DEXTROAMPHETAMINE SACCHARATE 3.125MG, DEXTROAMPHETAMINE SULFATE 3.125MG · TABLET · ORAL
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEPrescription
AMPHETAMINE ASPARTATE 7.5MG, AMPHETAMINE SULFATE 7.5MG, DEXTROAMPHETAMINE SACCHARATE 7.5MG, DEXTROAMPHETAMINE SULFATE 7.5MG · TABLET · ORAL
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEPrescription
AMPHETAMINE ASPARTATE 2.5MG, AMPHETAMINE SULFATE 2.5MG, DEXTROAMPHETAMINE SACCHARATE 2.5MG, DEXTROAMPHETAMINE SULFATE 2.5MG · TABLET · ORAL
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEPrescription
AMPHETAMINE ASPARTATE 3.75MG, AMPHETAMINE SULFATE 3.75MG, DEXTROAMPHETAMINE SACCHARATE 3.75MG, DEXTROAMPHETAMINE SULFATE 3.75MG · TABLET · ORAL
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEPrescription
AMPHETAMINE ASPARTATE 1.875MG, AMPHETAMINE SULFATE 1.875MG, DEXTROAMPHETAMINE SACCHARATE 1.875MG, DEXTROAMPHETAMINE SULFATE 1.875MG · TABLET · ORAL
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEPrescription
AMPHETAMINE ASPARTATE 5MG, AMPHETAMINE SULFATE 5MG, DEXTROAMPHETAMINE SACCHARATE 5MG, DEXTROAMPHETAMINE SULFATE 5MG · TABLET · ORAL
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEPrescription
AMPHETAMINE ASPARTATE 1.25MG, AMPHETAMINE SULFATE 1.25MG, DEXTROAMPHETAMINE SACCHARATE 1.25MG, DEXTROAMPHETAMINE SULFATE 1.25MG · TABLET · ORAL
Approval history
2023-10-13Labeling · Supplement 37 · standardAP
2022-02-25Labeling · Supplement 33 · standardAP
2022-02-25Labeling · Supplement 32 · standardAP
2022-02-25Labeling · Supplement 24 · standardAP
2017-01-04Labeling · Supplement 22 · standardAP
2015-04-17Labeling · Supplement 18 · standardAP
2015-02-04Labeling · Supplement 16 · standardAP
2015-02-04Labeling · Supplement 14 · standardAP
2014-11-03Labeling · Supplement 7AP
2014-11-03Manufacturing (CMC) · Supplement 6AP
2013-12-31Labeling · Supplement 12 · standardAP
2009-05-28Labeling · Supplement 5AP
2009-05-28Labeling · Supplement 3AP
2009-05-28Labeling · Supplement 4AP
2002-12-19Manufacturing (CMC) · Supplement 1AP
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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