APPLICATION
ANDA081226
TYPE
ANDA
ORIGINAL APPROVAL
1992-10-27
LATEST ACTION
2002-08-13
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 500MG/15ML, HYDROCODONE BITARTRATE 5MG/15ML · SOLUTION · ORAL
Approval history
2002-08-13Manufacturing (CMC) · Supplement 5AP
1998-07-31Manufacturing (CMC) · Supplement 4AP
1996-01-18Manufacturing (CMC) · Supplement 2AP
1995-07-25Manufacturing (CMC) · Supplement 1AP
1992-10-27OriginalAP
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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