APPLICATION
NDA010093
TYPE
NDA
ORIGINAL APPROVAL
1955-09-09
LATEST ACTION
1983-06-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
BIPHETAMINE 7.5Discontinued
AMPHETAMINE RESIN COMPLEX EQ 3.75MG BASE, DEXTROAMPHETAMINE RESIN COMPLEX EQ 3.75MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
BIPHETAMINE 12.5Discontinued
AMPHETAMINE RESIN COMPLEX EQ 6.25MG BASE, DEXTROAMPHETAMINE RESIN COMPLEX EQ 6.25MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
BIPHETAMINE 20Discontinued
AMPHETAMINE RESIN COMPLEX EQ 10MG BASE, DEXTROAMPHETAMINE RESIN COMPLEX EQ 10MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
1983-06-16Manufacturing (CMC) · Supplement 13 · standardAP
1983-05-06Manufacturing (CMC) · Supplement 12 · standardAP
1979-04-04Labeling · Supplement 11 · standardAP
1955-09-09Type 2 - New Active Ingredient · Original · standardAP
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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