← FDA DRUG APPROVALS
FDA ANDA · ANDA070607
ACETAMINOPHEN FOR CHILDREN
acetaminophen
Sponsor: PERRIGO NEW YORK
APPLICATION
ANDA070607
TYPE
ANDA
ORIGINAL APPROVAL
1987-04-06
LATEST ACTION
2015-09-24
ROUTE
RECTAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Over-the-counter
Products
ACETAMINOPHENOver-the-counter
ACETAMINOPHEN 120MG · SUPPOSITORY · RECTAL
Approval history
2015-09-24Labeling · Supplement 8 · standardAP
2011-06-08Labeling · Supplement 7AP
2010-08-06Labeling · Supplement 6AP
1992-08-31Labeling · Supplement 3AP
1987-10-23Manufacturing (CMC) · Supplement 2AP
1987-04-06OriginalAP
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.