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FDA ANDA · ANDA084935

DEXEDRINE

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APPLICATION
ANDA084935
TYPE
ANDA
ORIGINAL APPROVAL
1976-02-26
LATEST ACTION
2007-08-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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DEXTROAMPHETAMINE SULFATE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2007-08-17Labeling · Supplement 25AP
2006-08-23Labeling · Supplement 24AP
2000-11-28Manufacturing (CMC) · Supplement 21AP
2000-02-24Manufacturing (CMC) · Supplement 20AP
1999-10-27Manufacturing (CMC) · Supplement 19AP
1998-07-30Manufacturing (CMC) · Supplement 18AP
1997-04-22Labeling · Supplement 16AP
1991-08-22Manufacturing (CMC) · Supplement 14AP
1991-08-22Labeling · Supplement 15AP
1982-06-30Manufacturing (CMC) · Supplement 8AP
1982-05-17Manufacturing (CMC) · Supplement 9AP
1976-02-26Original — 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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