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FDA ANDA · ANDA076475
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Sponsor: CHARTWELL RX
APPLICATION
ANDA076475
TYPE
ANDA
ORIGINAL APPROVAL
2005-04-21
LATEST ACTION
2025-12-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 325MG, TRAMADOL HYDROCHLORIDE 37.5MG · TABLET · ORAL
Approval history
2025-12-29Labeling · Supplement 25 · standardAP
2023-12-15Labeling · Supplement 24 · standardAP
2018-09-18REMS · Supplement 19AP
2016-06-20Labeling · Supplement 16 · standardAP
2014-08-01Labeling · Supplement 15 · standardAP
2011-10-31Labeling · Supplement 14AP
2011-10-11Labeling · Supplement 12AP
2011-03-25Labeling · Supplement 10AP
2007-01-12Labeling · 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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