APPLICATION
ANDA088577
TYPE
ANDA
ORIGINAL APPROVAL
1984-12-21
LATEST ACTION
1990-01-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 500MG, HYDROCODONE BITARTRATE 5MG · TABLET · ORAL
Approval history
1990-01-19Labeling · Supplement 19AP
1990-01-19Labeling · Supplement 21AP
1989-10-02Labeling · Supplement 24AP
1988-12-20Labeling · Supplement 23AP
1988-05-18Labeling · Supplement 17AP
1988-03-17Labeling · Supplement 16AP
1984-12-21OriginalAP
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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