← FDA DRUG APPROVALS

FDA ANDA · ANDA206885

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Sponsor: MACLEODS PHARMS LTD

APPLICATION
ANDA206885
TYPE
ANDA
ORIGINAL APPROVAL
2017-05-02
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 33AP
2025-12-29Labeling · Supplement 32 · standardAP
2025-12-15Labeling · Supplement 28 · standardAP
2024-10-31REMS · Supplement 29AP
2023-12-15Labeling · Supplement 27 · standardAP
2023-12-15Labeling · Supplement 25 · standardAP
2023-12-08Labeling · Supplement 11 · standardAP
2023-12-08Labeling · Supplement 1 · standardAP
2023-12-08Labeling · Supplement 18 · standardAP
2023-12-08Labeling · Supplement 14 · standardAP
2023-12-08Labeling · Supplement 20 · standardAP
2023-12-08Labeling · Supplement 23 · standardAP
2023-06-07Labeling · Supplement 21 · standardAP
2018-09-18REMS · Supplement 10AP
2017-05-02UNKNOWN · Original · standard — REMS ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →