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FDA ANDA · ANDA090460
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Sponsor: ZYDUS PHARMS USA INC
APPLICATION
ANDA090460
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-06
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 21AP
2025-12-23Labeling · Supplement 19 · standardAP
2025-12-15Labeling · Supplement 17 · standardAP
2024-10-31REMS · Supplement 18AP
2023-12-15Labeling · Supplement 16 · standardAP
2023-12-01Labeling · Supplement 11 · standardAP
2023-12-01Labeling · Supplement 14 · standardAP
2023-12-01Labeling · Supplement 7 · standardAP
2018-09-18REMS · Supplement 9AP
2017-03-23Labeling · Supplement 6 · standardAP
2016-06-20Labeling · Supplement 3 · standardAP
2014-08-01Labeling · Supplement 2 · standardAP
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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