APPLICATION
ANDA040117
TYPE
ANDA
ORIGINAL APPROVAL
1996-09-23
LATEST ACTION
2001-05-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
VICODIN HPDiscontinued
ACETAMINOPHEN 660MG, HYDROCODONE BITARTRATE 10MG · TABLET · ORAL
Approval history
2001-05-01Manufacturing (CMC) · Supplement 3AP
2000-06-27Manufacturing (CMC) · Supplement 2AP
2000-02-15Manufacturing (CMC) · Supplement 1AP
1996-09-23OriginalAP
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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