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FDA ANDA · ANDA076353

DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE

dextroamphetamine sulfate

Sponsor: SPECGX LLC

APPLICATION
ANDA076353
TYPE
ANDA
ORIGINAL APPROVAL
2003-05-06
LATEST ACTION
2016-10-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

DEXTROAMPHETAMINE SULFATEPrescription
DEXTROAMPHETAMINE SULFATE 10MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXTROAMPHETAMINE SULFATEPrescription
DEXTROAMPHETAMINE SULFATE 15MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXTROAMPHETAMINE SULFATEPrescription
DEXTROAMPHETAMINE SULFATE 5MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2016-10-25Labeling · Supplement 13 · standardAP
2015-08-24Labeling · Supplement 10 · standardAP
2015-03-02Labeling · Supplement 7 · standardAP
2015-03-02Labeling · Supplement 8 · standardAP
2011-09-30Labeling · Supplement 6AP
2008-01-16Labeling · Supplement 5AP
2007-08-31Labeling · Supplement 4AP
2007-03-23Labeling · Supplement 3AP
2003-05-06OriginalAP
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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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