APPLICATION
ANDA205702
TYPE
ANDA
ORIGINAL APPROVAL
2015-09-25
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 33AP
2025-12-29Labeling · Supplement 32 · standardAP
2025-05-06Labeling · Supplement 28 · standardAP
2024-10-31REMS · Supplement 29AP
2023-12-15Labeling · Supplement 27 · standardAP
2023-12-15Labeling · Supplement 25 · standardAP
2023-10-19Labeling · Supplement 23 · standardAP
2023-10-19Labeling · Supplement 15 · standardAP
2023-10-19Labeling · Supplement 2 · standardAP
2023-10-19Labeling · Supplement 12 · standardAP
2023-10-19Labeling · Supplement 10 · standardAP
2023-10-19Labeling · Supplement 19 · standardAP
2023-06-07Labeling · Supplement 22 · standardAP
2018-09-18REMS · Supplement 7AP
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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