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FDA ANDA · ANDA090485
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Sponsor: AMNEAL PHARMS
APPLICATION
ANDA090485
TYPE
ANDA
ORIGINAL APPROVAL
2009-12-09
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 325MG, TRAMADOL HYDROCHLORIDE 37.5MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 39AP
2025-12-23Labeling · Supplement 36 · standardAP
2025-12-15Labeling · Supplement 33 · standardAP
2024-10-31REMS · Supplement 34AP
2023-12-19Labeling · Supplement 32 · standardAP
2023-12-15Labeling · Supplement 22 · standardAP
2023-12-15Labeling · Supplement 27 · standardAP
2023-12-15Labeling · Supplement 25 · standardAP
2023-12-15Labeling · Supplement 17 · standardAP
2023-12-15Labeling · Supplement 31 · standardAP
2023-12-15Labeling · Supplement 28 · standardAP
2018-09-18REMS · Supplement 16AP
2018-04-26Labeling · Supplement 14 · standardAP
2018-04-26Labeling · Supplement 13 · standardAP
2016-07-27Labeling · Supplement 10 · standardAP
2016-07-27Labeling · Supplement 11 · standardAP
2014-07-08Labeling · Supplement 9 · standardAP
2011-12-13Labeling · Supplement 3AP
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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