APPLICATION
ANDA072344
TYPE
ANDA
ORIGINAL APPROVAL
1992-03-27
LATEST ACTION
2015-04-02
ROUTE
RECTAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Discontinued
Products
ACEPHENDiscontinued
ACETAMINOPHEN 325MG · SUPPOSITORY · RECTAL
Approval history
2015-04-02Labeling · Supplement 9AP
2010-08-19Labeling · Supplement 8AP
1999-04-29Manufacturing (CMC) · Supplement 4AP
1996-10-04Manufacturing (CMC) · Supplement 3AP
1995-11-01Manufacturing (CMC) · Supplement 2AP
1993-04-06Labeling · Supplement 1AP
1992-03-27OriginalAP
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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