APPLICATION
ANDA087743
TYPE
ANDA
ORIGINAL APPROVAL
1982-06-04
LATEST ACTION
1991-02-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ROXIPRINDiscontinued
ASPIRIN 325MG, OXYCODONE HYDROCHLORIDE 4.5MG, OXYCODONE TEREPHTHALATE 0.38MG · TABLET · ORAL
Approval history
1991-02-11Labeling · Supplement 9AP
1990-05-11Labeling · Supplement 8AP
1988-05-12Labeling · Supplement 4AP
1982-06-04OriginalAP
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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