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FDA ANDA · ANDA079113
UP AND UP IBUPROFEN PM
diphenhydramine citrate and ibuprofen
Sponsor: PERRIGO R AND D
APPLICATION
ANDA079113
TYPE
ANDA
ORIGINAL APPROVAL
2008-12-22
LATEST ACTION
2016-11-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
IBUPROFEN AND DIPHENHYDRAMINE CITRATEOver-the-counter
DIPHENHYDRAMINE CITRATE 38MG, IBUPROFEN 200MG · TABLET · ORAL
Approval history
2016-11-02Manufacturing (CMC) · Supplement 21 · unknownAP
2014-12-31Labeling · Supplement 5AP
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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