APPLICATION
ANDA085375
TYPE
ANDA
LATEST ACTION
1984-10-02
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
TYLOXDiscontinued
ACETAMINOPHEN 500MG, OXYCODONE HYDROCHLORIDE 4.5MG, OXYCODONE TEREPHTHALATE 0.38MG · CAPSULE · ORAL
Approval history
1984-10-02Manufacturing (CMC) · Supplement 11AP
1984-05-15Manufacturing (CMC) · Supplement 13AP
1983-01-31Manufacturing (CMC) · Supplement 12AP
1982-05-13Manufacturing (CMC) · Supplement 9AP
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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