APPLICATION
NDA016401
TYPE
NDA
ORIGINAL APPROVAL
1968-11-07
LATEST ACTION
1978-10-16
ROUTE
RECTAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Discontinued
Products
NEOPAPDiscontinued
ACETAMINOPHEN 120MG · SUPPOSITORY · RECTAL
Approval history
1978-10-16Labeling · Supplement 12AP
1977-10-18Manufacturing (CMC) · Supplement 11 · standardAP
1968-11-07Type 3 - New Dosage Form · 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.
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