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FDA ANDA · ANDA084051

DEXTROSTAT

Sponsor: SHIRE

APPLICATION
ANDA084051
TYPE
ANDA
ORIGINAL APPROVAL
1975-05-29
LATEST ACTION
2002-11-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

DEXTROSTAT · ReferenceDiscontinued
DEXTROAMPHETAMINE SULFATE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
DEXTROSTAT · ReferenceDiscontinued
DEXTROAMPHETAMINE SULFATE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2002-11-20Manufacturing (CMC) · Supplement 24AP
2002-01-17Manufacturing (CMC) · Supplement 23AP
2000-02-28Manufacturing (CMC) · Supplement 22AP
2000-01-27Manufacturing (CMC) · Supplement 21AP
1998-10-26Labeling · Supplement 20AP
1998-05-13Labeling · Supplement 18AP
1998-04-15Manufacturing (CMC) · Supplement 19AP
1998-01-09Manufacturing (CMC) · Supplement 12AP
1997-09-26Manufacturing (CMC) · Supplement 17AP
1997-09-26Manufacturing (CMC) · Supplement 16AP
1997-08-18Labeling · Supplement 15AP
1997-08-18Labeling · Supplement 13AP
1997-02-28Manufacturing (CMC) · Supplement 14AP
1995-12-08Manufacturing (CMC) · Supplement 10AP
1995-12-08Manufacturing (CMC) · Supplement 11AP
1990-05-29Labeling · Supplement 9AP
1975-05-29Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

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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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