APPLICATION
ANDA201973
TYPE
ANDA
ORIGINAL APPROVAL
2012-11-16
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TRAMADOL HYDROCHLORIDEDiscontinued
TRAMADOL HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 14AP
2025-12-29Labeling · Supplement 13 · standardAP
2024-10-31REMS · Supplement 11AP
2023-12-15Labeling · Supplement 10 · standardAP
2023-09-12Labeling · Supplement 9 · standardAP
2023-01-17Labeling · Supplement 8 · standardAP
2023-01-17Labeling · Supplement 6 · standardAP
2023-01-17Labeling · Supplement 4 · standardAP
2023-01-17Labeling · Supplement 2 · standardAP
2023-01-17Labeling · Supplement 7 · standardAP
2023-01-17Labeling · Supplement 5 · standardAP
2023-01-17Labeling · Supplement 1 · 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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