APPLICATION
ANDA076137
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-18
LATEST ACTION
2015-12-28
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
DEXTROAMPHETAMINE SULFATEDiscontinued
DEXTROAMPHETAMINE SULFATE 10MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXTROAMPHETAMINE SULFATEDiscontinued
DEXTROAMPHETAMINE SULFATE 15MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXTROAMPHETAMINE SULFATEDiscontinued
DEXTROAMPHETAMINE SULFATE 5MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2015-12-28Labeling · Supplement 17 · standardAP
2015-03-02Labeling · Supplement 14 · standardAP
2014-01-28Labeling · Supplement 13 · standardAP
2011-10-13Labeling · Supplement 10AP
2007-08-31Labeling · Supplement 7AP
2007-03-23Labeling · Supplement 6AP
2002-11-05Manufacturing (CMC) · Supplement 2AP
2002-06-18Manufacturing (CMC) · Supplement 1AP
2002-01-18OriginalAP
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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