APPLICATION
ANDA078783
TYPE
ANDA
ORIGINAL APPROVAL
2009-11-13
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
TRAMADOL HYDROCHLORIDEDiscontinued
TRAMADOL HYDROCHLORIDE 300MG · TABLET, EXTENDED RELEASE · ORAL
TRAMADOL HYDROCHLORIDEDiscontinued
TRAMADOL HYDROCHLORIDE 100MG · TABLET, EXTENDED RELEASE · ORAL
TRAMADOL HYDROCHLORIDEDiscontinued
TRAMADOL HYDROCHLORIDE 200MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-06-18REMS · Supplement 18AP
2025-12-22Labeling · Supplement 17 · standardAP
2025-10-21Labeling · Supplement 15 · standardAP
2024-10-31REMS · Supplement 16AP
2023-12-15Labeling · Supplement 14 · standardAP
2021-09-10Labeling · Supplement 13 · standardAP
2021-03-04Labeling · Supplement 12 · standardAP
2019-10-09Labeling · Supplement 10 · standardAP
2018-09-21Labeling · Supplement 9 · standardAP
2018-09-18REMS · Supplement 8AP
2017-08-29Labeling · Supplement 7 · standardAP
2017-08-21Labeling · Supplement 6 · standardAP
2017-08-21Labeling · Supplement 4 · standardAP
2011-09-20Efficacy · Supplement 1AP
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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