APPLICATION
ANDA089166
TYPE
ANDA
ORIGINAL APPROVAL
1986-05-14
LATEST ACTION
1986-10-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
SYNALGOS-DC-ADiscontinued
ACETAMINOPHEN 356.4MG, CAFFEINE 30MG, DIHYDROCODEINE BITARTRATE 16MG · CAPSULE · ORAL
Approval history
1986-10-27Manufacturing (CMC) · Supplement 1AP
1986-09-10Manufacturing (CMC) · Supplement 2AP
1986-05-14OriginalAP
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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