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FDA ANDA · ANDA075077
TOPCARE 8 HR ARTHRITIS PAIN RELIEF
acetaminophen
Sponsor: PERRIGO
APPLICATION
ANDA075077
TYPE
ANDA
ORIGINAL APPROVAL
2000-02-25
LATEST ACTION
2019-08-16
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Over-the-counter
Products
ACETAMINOPHENOver-the-counter
ACETAMINOPHEN 650MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2019-08-16Labeling · Supplement 55 · standardAP
2016-01-10Labeling · Supplement 40 · standardAP
2013-11-30Labeling · Supplement 32AP
2010-10-25Labeling · Supplement 28AP
2005-02-10Labeling · Supplement 6AP
2000-12-29Labeling · Supplement 1AP
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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