APPLICATION
ANDA089907
TYPE
ANDA
ORIGINAL APPROVAL
1989-01-13
LATEST ACTION
1997-05-05
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
ALLAYDiscontinued
ACETAMINOPHEN 500MG, HYDROCODONE BITARTRATE 5MG · CAPSULE · ORAL
Approval history
1997-05-05Manufacturing (CMC) · Supplement 4AP
1997-01-31Labeling · Supplement 5AP
1991-03-25Labeling · Supplement 1AP
1989-01-13OriginalAP
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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