APPLICATION
ANDA040309
TYPE
ANDA
ORIGINAL APPROVAL
2000-07-26
LATEST ACTION
2001-08-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 500MG, HYDROCODONE BITARTRATE 10MG · TABLET · ORAL
Approval history
2001-08-23Manufacturing (CMC) · Supplement 1AP
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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