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FDA ANDA · ANDA201952
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Sponsor: MICRO LABS LTD INDIA
APPLICATION
ANDA201952
TYPE
ANDA
ORIGINAL APPROVAL
2012-12-14
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 325MG, TRAMADOL HYDROCHLORIDE 37.5MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 18AP
2025-12-22Labeling · Supplement 17 · standardAP
2025-12-12Labeling · Supplement 15 · standardAP
2024-10-31REMS · Supplement 16AP
2023-12-15Labeling · Supplement 14 · standardAP
2022-08-03Labeling · Supplement 13 · standardAP
2022-08-03Labeling · Supplement 8 · standardAP
2022-08-03Labeling · Supplement 11 · standardAP
2022-08-03Labeling · Supplement 12 · standardAP
2022-08-03Labeling · Supplement 7 · standardAP
2022-08-03Labeling · Supplement 10 · standardAP
2018-09-18REMS · Supplement 9AP
2017-03-23Labeling · Supplement 6 · standardAP
2014-08-01Labeling · Supplement 1 · 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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