APPLICATION
NDA018060
TYPE
NDA
ORIGINAL APPROVAL
1978-02-09
LATEST ACTION
2014-12-02
ROUTE
RECTAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Discontinued
Products
ACEPHENDiscontinued
ACETAMINOPHEN 325MG · SUPPOSITORY · RECTAL
ACEPHENDiscontinued
ACETAMINOPHEN 120MG · SUPPOSITORY · RECTAL
ACEPHENDiscontinued
ACETAMINOPHEN 650MG · SUPPOSITORY · RECTAL
Approval history
2014-12-02Manufacturing (CMC) · Supplement 67 · standardAP
2010-04-01Labeling · Supplement 64 · standardAP
2002-02-15Manufacturing (CMC) · Supplement 59 · standardAP
1999-03-24Manufacturing (CMC) · Supplement 58 · standardAP
1996-07-29Manufacturing (CMC) · Supplement 56 · standardAP
1987-10-20Labeling · Supplement 52AP
1987-08-26Labeling · Supplement 53AP
1986-12-17Manufacturing (CMC) · Supplement 50 · standardAP
1985-01-22Manufacturing (CMC) · Supplement 51 · standardAP
1983-05-11Manufacturing (CMC) · Supplement 49 · standardAP
1981-04-22Labeling · Supplement 48AP
1980-12-18Manufacturing (CMC) · Supplement 46 · standardAP
1980-11-25Manufacturing (CMC) · Supplement 44 · standardAP
1980-11-21Manufacturing (CMC) · Supplement 45 · standardAP
1980-11-19Labeling · Supplement 43AP
1980-08-12Labeling · Supplement 42AP
1980-03-06Manufacturing (CMC) · Supplement 20 · standardAP
1980-02-21Labeling · Supplement 39AP
1980-02-20Manufacturing (CMC) · Supplement 34 · standardAP
1980-02-13Labeling · Supplement 37AP
1980-02-13Labeling · Supplement 38AP
1980-02-13Labeling · Supplement 36AP
1979-11-06Manufacturing (CMC) · Supplement 25 · standardAP
1979-11-06Manufacturing (CMC) · Supplement 32 · standardAP
1979-11-05Labeling · Supplement 31AP
1979-11-05Manufacturing (CMC) · Supplement 30 · standardAP
1979-10-24Manufacturing (CMC) · Supplement 24 · standardAP
1979-10-22Labeling · Supplement 29AP
1979-09-27Manufacturing (CMC) · Supplement 23 · standardAP
1979-09-17Manufacturing (CMC) · Supplement 19 · standardAP
1979-09-14Manufacturing (CMC) · Supplement 22 · standardAP
1979-09-12Manufacturing (CMC) · Supplement 27 · standardAP
1979-09-11Labeling · Supplement 33AP
1979-04-13Labeling · Supplement 21AP
1979-03-15Manufacturing (CMC) · Supplement 18 · standardAP
1978-10-06Labeling · Supplement 15AP
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.