Tramadol Hydrochloride · Regulatory label update

FDA supplemental approval: Tramadol Hydrochloride Extended-release (REMS)

U.S. Food and Drug Administration · June 18, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

The FDA approved a supplemental REMS (Risk Evaluation and Mitigation Strategy) for tramadol hydrochloride extended-release capsules (CONZIP) on 18 June 2026. This regulatory action governs risk mitigation and safe use conditions for the product; it does not report efficacy, safety outcomes, or comparative clinical trial data.

What was studied

Regulatory label update.

Key findings

FDA supplemental approval granted for tramadol hydrochloride extended-release REMS on 2026-06-18 Four extended-release capsule strengths approved: 100 mg, 150 mg, 200 mg, 300 mg

Safety

Record contains no clinical trial results, efficacy data, or safety outcome comparisons

Who this may help

This record documents a regulatory REMS requirement and does not provide evidence on clinical efficacy or safety outcomes. Clinicians should refer to the approved REMS program documentation and product labeling for prescribing guidance and risk mitigation requirements.

Plain-language summary

FDA supplemental approval for a Risk Evaluation and Mitigation Strategy (REMS) on an existing tramadol extended-release product; a regulatory action without clinical trial data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-18

Approved strengths100 mg, 150 mg, 200 mg, 300 mg

Clinical bottom line

Caveats

Record contains no clinical trial results, efficacy data, or safety outcome comparisons
No sample size, patient population demographics, or endpoints reported
Record is a regulatory action summary; clinical evidence supporting the REMS is not included here

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

insufficient

This is a regulatory action record, not a clinical study.

Directness

insufficient

Record contains no clinical efficacy or safety outcome data.

Consistency

insufficient

No comparative or confirmatory clinical data provided in record.

Risk of bias

insufficient

Not applicable; regulatory action does not report trial outcomes.

Sample adequacy

insufficient

No clinical trial sample size or population data provided.

Source abstract

Drugs@FDA record for application NDA022370. This is a regulatory action record, not a clinical study. Brand name: TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE. Active ingredient: TRAMADOL HYDROCHLORIDE. Sponsor: CIPHER PHARMS INC. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: CONZIP, CAPSULE, EXTENDED RELEASE, ORAL, TRAMADOL HYDROCHLORIDE 150MG; CONZIP, CAPSULE, EXTENDED RELEASE, ORAL, TRAMADOL HYDROCHLORIDE 200MG; CONZIP, CAPSULE, EXTENDED RELEASE, ORAL, TRAMADOL HYDROCHLORIDE 300MG; CONZIP, CAPSULE, EXTENDED RELEASE, ORAL, TRAMADOL HYDROCHLORIDE 100MG.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Tramadol HydrochlorideCipher Pharms