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FDA ANDA · ANDA075981

TRAMADOL HYDROCHLORIDE

Sponsor: APOTEX

APPLICATION
ANDA075981
TYPE
ANDA
ORIGINAL APPROVAL
2002-07-10
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 30AP
2025-12-22Labeling · Supplement 29 · standardAP
2025-12-15Labeling · Supplement 27 · standardAP
2024-10-31REMS · Supplement 28AP
2023-12-15Labeling · Supplement 26 · standardAP
2023-12-15Labeling · Supplement 25 · standardAP
2023-10-19Labeling · Supplement 21 · standardAP
2023-10-19Labeling · Supplement 24 · standardAP
2023-10-19Labeling · Supplement 16 · standardAP
2023-10-19Labeling · Supplement 22 · standardAP
2023-10-19Labeling · Supplement 20 · standardAP
2023-10-19Labeling · Supplement 19 · standardAP
2023-10-19Labeling · Supplement 17 · standardAP
2023-10-19Labeling · Supplement 23 · standardAP
2018-09-18REMS · Supplement 18AP
2015-11-13Labeling · Supplement 13 · standardAP
2008-08-27Labeling · Supplement 7AP
2003-11-03Labeling · Supplement 2AP
2002-07-10Original — REMS ↗AP
VIEW ON DRUGS@FDA ↗

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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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