APPLICATION
ANDA087677
TYPE
ANDA
ORIGINAL APPROVAL
1982-05-03
LATEST ACTION
1995-03-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HY-PHENDiscontinued
ACETAMINOPHEN 500MG, HYDROCODONE BITARTRATE 5MG · TABLET · ORAL
Approval history
1995-03-09Labeling · Supplement 10AP
1993-10-14Labeling · Supplement 9AP
1992-10-27Manufacturing (CMC) · Supplement 8AP
1986-12-29Manufacturing (CMC) · Supplement 5AP
1983-08-01Manufacturing (CMC) · Supplement 1AP
1982-05-03OriginalAP
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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