APPLICATION
ANDA083564
TYPE
ANDA
ORIGINAL APPROVAL
1975-10-24
LATEST ACTION
1975-10-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
DELCOBESEDiscontinued
AMPHETAMINE ADIPATE 1.25MG, AMPHETAMINE SULFATE 1.25MG, DEXTROAMPHETAMINE ADIPATE 1.25MG, DEXTROAMPHETAMINE SULFATE 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
DELCOBESEDiscontinued
AMPHETAMINE ADIPATE 5MG, AMPHETAMINE SULFATE 5MG, DEXTROAMPHETAMINE ADIPATE 5MG, DEXTROAMPHETAMINE SULFATE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
DELCOBESEDiscontinued
AMPHETAMINE ADIPATE 2.5MG, AMPHETAMINE SULFATE 2.5MG, DEXTROAMPHETAMINE ADIPATE 2.5MG, DEXTROAMPHETAMINE SULFATE 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
DELCOBESEDiscontinued
AMPHETAMINE ADIPATE 3.75MG, AMPHETAMINE SULFATE 3.75MG, DEXTROAMPHETAMINE ADIPATE 3.75MG, DEXTROAMPHETAMINE SULFATE 3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
Approval history
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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