← FDA DRUG APPROVALS
FDA ANDA · ANDA076852
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate
Sponsor: IMPAX LABS
APPLICATION
ANDA076852
TYPE
ANDA
ORIGINAL APPROVAL
2016-02-16
LATEST ACTION
2024-08-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
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 · CAPSULE, EXTENDED RELEASE · ORAL
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEPrescription
AMPHETAMINE ASPARTATE 5MG, AMPHETAMINE SULFATE 5MG, DEXTROAMPHETAMINE SACCHARATE 5MG, DEXTROAMPHETAMINE SULFATE 5MG · CAPSULE, EXTENDED RELEASE · 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 · CAPSULE, EXTENDED RELEASE · ORAL
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEPrescription
AMPHETAMINE ASPARTATE 6.25MG, AMPHETAMINE SULFATE 6.25MG, DEXTROAMPHETAMINE SACCHARATE 6.25MG, DEXTROAMPHETAMINE SULFATE 6.25MG · CAPSULE, EXTENDED RELEASE · 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 · CAPSULE, EXTENDED RELEASE · 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 · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2024-08-30Labeling · Supplement 19 · standardAP
2024-08-30Labeling · Supplement 21 · standardAP
2024-08-30Labeling · Supplement 6 · standardAP
2024-08-30Labeling · Supplement 26 · standardAP
2024-08-30Labeling · Supplement 14 · standardAP
2024-08-30Labeling · Supplement 12 · standardAP
2016-02-16OriginalAP
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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