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FDA ANDA · ANDA040440
DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
Sponsor: SPECGX LLC
APPLICATION
ANDA040440
TYPE
ANDA
ORIGINAL APPROVAL
2003-10-07
LATEST ACTION
2023-10-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
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 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 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 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 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 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 1.25MG, AMPHETAMINE SULFATE 1.25MG, DEXTROAMPHETAMINE SACCHARATE 1.25MG, DEXTROAMPHETAMINE SULFATE 1.25MG · TABLET · ORAL
Approval history
2023-10-20Labeling · Supplement 29 · standardAP
2022-02-25Labeling · Supplement 26 · standardAP
2017-01-04Labeling · Supplement 19 · standardAP
2016-10-28Labeling · Supplement 13 · standardAP
2016-10-28Labeling · Supplement 16 · standardAP
2015-04-17Labeling · Supplement 12 · standardAP
2015-01-29Labeling · Supplement 11 · standardAP
2014-03-13Labeling · Supplement 5 · standardAP
2003-10-07OriginalAP
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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