← FDA DRUG APPROVALS

FDA ANDA · ANDA040422

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE

Sponsor: BARR

APPLICATION
ANDA040422
TYPE
ANDA
ORIGINAL APPROVAL
2002-02-11
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 59 · standardAP
2023-03-07Labeling · Supplement 58 · standardAP
2022-02-25Labeling · Supplement 57 · standardAP
2022-02-14Labeling · Supplement 56 · standardAP
2017-01-04Labeling · Supplement 44 · standardAP
2016-09-27Labeling · Supplement 42 · standardAP
2015-10-23Labeling · Supplement 20AP
2015-04-17Labeling · Supplement 38 · standard — Label ↗AP
2014-06-10Labeling · Supplement 36 · standard — Label ↗AP
2014-02-13Labeling · Supplement 33 · standard — Label ↗AP
2014-02-13Labeling · Supplement 34 · standard — Label ↗AP
2013-09-25Labeling · Supplement 30 · standard — Label ↗AP
2012-03-27Labeling · Supplement 26AP
2009-08-11Labeling · Supplement 22AP
2008-08-11Labeling · Supplement 24AP
2003-03-19Labeling · Supplement 6AP
2002-09-11Manufacturing (CMC) · Supplement 1AP
2002-02-11Original — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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