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FDA ANDA · ANDA070608
ACETAMINOPHEN PAIN RELIEVER FEVER REDUCER
acetaminophen
Sponsor: PERRIGO NEW YORK
APPLICATION
ANDA070608
TYPE
ANDA
ORIGINAL APPROVAL
1986-12-01
LATEST ACTION
2015-09-24
ROUTE
RECTAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Over-the-counter
Products
ACETAMINOPHENOver-the-counter
ACETAMINOPHEN 650MG · SUPPOSITORY · RECTAL
Approval history
2015-09-24Labeling · Supplement 10 · standardAP
2011-06-10Labeling · Supplement 9AP
2010-08-06Labeling · Supplement 8AP
1992-08-31Labeling · Supplement 5AP
1987-10-23Manufacturing (CMC) · Supplement 2AP
1986-12-01OriginalAP
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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