← FDA DRUG APPROVALS
FDA ANDA · ANDA075794
DG HEALTH MIGRAINE RELIEF
acetaminophen, aspirin, caffeine
Sponsor: PERRIGO
APPLICATION
ANDA075794
TYPE
ANDA
ORIGINAL APPROVAL
2001-11-26
LATEST ACTION
2016-02-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
ACETAMINOPHEN, ASPIRIN AND CAFFEINEOver-the-counter
ACETAMINOPHEN 250MG, ASPIRIN 250MG, CAFFEINE 65MG · TABLET · ORAL
Approval history
2016-02-26Manufacturing (CMC) · Supplement 45AP
2014-12-12Labeling · Supplement 40 · standardAP
2010-11-22Labeling · Supplement 30AP
2008-03-05Labeling · Supplement 26AP
2006-11-21Labeling · Supplement 22AP
2003-12-17Labeling · Supplement 12AP
2003-10-08Labeling · Supplement 8AP
2002-08-16Manufacturing (CMC) · Supplement 2AP
2002-08-16Labeling · Supplement 3AP
2002-08-16Manufacturing (CMC) · Supplement 1AP
2002-08-16Manufacturing (CMC) · Supplement 4AP
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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