Hydrocodone Bitartrate · Regulatory label update

FDA supplemental approval: Hydrocodone Bitartrate AND Ibuprofen (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

This is a regulatory action record documenting FDA approval of a supplemental REMS application for hydrocodone bitartrate and ibuprofen combination tablets at three dose strengths (5/200 mg, 7.5/200 mg, and 10/200 mg) by Strides Pharma, effective 18 June 2026. The record does not contain clinical trial outcomes, efficacy data, or comparative benefit information; it reflects administrative compliance with risk mitigation requirements for this controlled analgesic combination.

What was studied

Regulatory label update.

Key findings

REMS supplement approved for hydrocodone bitartrate (5 mg, 7.5 mg, 10 mg) + ibuprofen 200 mg tablets on 2026-06-18 Sponsor: Strides Pharma; ANDA application 077723

Safety

Record contains no clinical trial data, efficacy results, or safety outcomes. Sponsor: Strides Pharma; ANDA application 077723

Who this may help

This record documents regulatory approval of a REMS for an existing combination product; it does not report efficacy, safety trial results, or clinical outcomes. Clinicians should consult the product labelling and full REMS materials for prescribing information and risk mitigation obligations.

Plain-language summary

FDA supplemental approval of a REMS (Risk Evaluation and Mitigation Strategy) for hydrocodone bitartrate and ibuprofen combination tablets; regulatory action does not report clinical trial data or efficacy evidence.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-18

Dose strength 1Hydrocodone bitartrate 5 mg + ibuprofen 200 mg

Dose strength 2Hydrocodone bitartrate 7.5 mg + ibuprofen 200 mg

Dose strength 3Hydrocodone bitartrate 10 mg + ibuprofen 200 mg

Clinical bottom line

Caveats

Record contains no clinical trial data, efficacy results, or safety outcomes.
REMS details (specific requirements, communication plan, elements to assure safe use) are not described in this regulatory summary.
No comparator, control group, or comparative effectiveness information provided.
Approval of REMS does not imply new clinical evidence; may reflect administrative or formulation changes.

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

Regulatory approval record; no study design present.

Directness

insufficient

No clinical outcome data reported; REMS administrative action only.

Consistency

insufficient

Single regulatory action; no comparative evidence or replication.

Risk of bias

insufficient

No clinical trial methods or bias assessment applicable.

Sample adequacy

insufficient

No sample size or population study data reported.

Source abstract

Drugs@FDA record for application ANDA077723. This is a regulatory action record, not a clinical study. Brand name: HYDROCODONE BITARTRATE AND IBUPROFEN. Active ingredient: HYDROCODONE BITARTRATE. Sponsor: STRIDES PHARMA. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: HYDROCODONE BITARTRATE AND IBUPROFEN, TABLET, ORAL, HYDROCODONE BITARTRATE 10MG + IBUPROFEN 200MG; HYDROCODONE, TABLET, ORAL, HYDROCODONE BITARTRATE 5MG + IBUPROFEN 200MG; HYDROCODONE BITARTRATE AND IBUPROFEN, TABLET, ORAL, HYDROCODONE BITARTRATE 7.5MG + IBUPROFEN 200MG.

Follow from this

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

Strides PharmaHydrocodone Bitartrate