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FDA ANDA · ANDA083902

DEXEDRINE

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APPLICATION
ANDA083902
TYPE
ANDA
ORIGINAL APPROVAL
1976-02-26
LATEST ACTION
2000-11-28
ROUTE
ORAL
DOSAGE FORM
ELIXIR
MARKETING STATUS
Discontinued

Products

DEXEDRINEDiscontinued
DEXTROAMPHETAMINE SULFATE 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · ELIXIR · ORAL

Approval history

2000-11-28Manufacturing (CMC) · Supplement 4AP
1999-10-27Manufacturing (CMC) · Supplement 3AP
1998-08-14Manufacturing (CMC) · Supplement 2AP
1976-02-26Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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