← FDA DRUG APPROVALS

FDA ANDA · ANDA040439

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE

Sponsor: SANDOZ

APPLICATION
ANDA040439
TYPE
ANDA
ORIGINAL APPROVAL
2002-06-14
LATEST ACTION
2024-06-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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 1.25MG, AMPHETAMINE SULFATE 1.25MG, DEXTROAMPHETAMINE SACCHARATE 1.25MG, DEXTROAMPHETAMINE SULFATE 1.25MG · 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

Approval history

2024-06-14Labeling · Supplement 34 · standardAP
2023-10-13Labeling · Supplement 32 · standardAP
2023-02-07Labeling · Supplement 30 · standardAP
2022-02-25Labeling · Supplement 29 · standardAP
2017-01-04Labeling · Supplement 20 · standardAP
2015-04-17Labeling · Supplement 18 · standardAP
2015-01-29Labeling · Supplement 17 · standardAP
2015-01-29Labeling · Supplement 15 · standardAP
2010-09-23Labeling · Supplement 8AP
2010-09-23Labeling · Supplement 10AP
2010-09-23Labeling · Supplement 7AP
2002-12-09Manufacturing (CMC) · Supplement 1AP
2002-06-14Original — Letter ↗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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