APPLICATION
NDA018337
TYPE
NDA
ORIGINAL APPROVAL
1980-04-22
LATEST ACTION
2020-02-07
ROUTE
RECTAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Over-the-counter, Discontinued
Products
ACETAMINOPHEN · ReferenceOver-the-counter
ACETAMINOPHEN 120MG · SUPPOSITORY · RECTAL
ACETAMINOPHEN · ReferenceDiscontinued
ACETAMINOPHEN 650MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SUPPOSITORY · RECTAL
INFANTS' FEVERALL · ReferenceOver-the-counter
ACETAMINOPHEN 80MG · SUPPOSITORY · RECTAL
ACETAMINOPHEN · ReferenceOver-the-counter
ACETAMINOPHEN 325MG · SUPPOSITORY · RECTAL
Approval history
2015-01-05Manufacturing (CMC) · Supplement 33 · standardAP
2010-10-20Labeling · Supplement 29 · standardAP
2002-10-09Manufacturing (CMC) · Supplement 20 · standardAP
2000-09-21Manufacturing (CMC) · Supplement 16 · standardAP
1994-06-15Manufacturing (CMC) · Supplement 15 · standardAP
1993-01-28Manufacturing (CMC) · Supplement 12 · standardAP
1988-06-08Labeling · Supplement 8AP
1980-04-22Type 5 - New Formulation or New Manufacturer · Original · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.