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FDA ANDA · ANDA202076
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Sponsor: ALKEM LABS LTD
APPLICATION
ANDA202076
TYPE
ANDA
ORIGINAL APPROVAL
2012-03-30
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 10AP
2025-12-29Labeling · Supplement 9 · standardAP
2025-12-15Labeling · Supplement 7 · standardAP
2024-10-31REMS · Supplement 8AP
2023-12-15Labeling · Supplement 6 · standardAP
2023-12-13Labeling · Supplement 5 · standardAP
2022-09-14Labeling · Supplement 4 · standardAP
2022-09-14Labeling · Supplement 2 · standardAP
2018-09-18REMS · 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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