Promethazine Hydrochloride AND Dextromethorphan Hydrobromide · Regulatory approval

FDA approval: Promethazine Hydrochloride AND Dextromethorphan Hydrobromide

U.S. Food and Drug Administration · March 12, 2026

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AI Summary

The FDA has approved an abbreviated new drug application (ANDA 218264) for a fixed-dose combination of promethazine hydrochloride and dextromethorphan hydrobromide as an oral syrup formulation. This is a regulatory manufacturing and quality approval, not a clinical efficacy study; no trial data, comparators, or patient outcomes are reported.

What was studied

Regulatory approval.

Key findings

Approval granted 2026-03-12 for promethazine HCl 6.25 mg/5 mL + dextromethorphan HBr 15 mg/5 mL oral syrup Sponsor: Hetero Labs Ltd III; submission type: original ANDA application

Safety

No information on indication, dosing regimen, patient population, contraindications, or adverse event profile is provided in this record.

Who this may help

This approval permits manufacture and marketing of the combination product. Clinicians should consult product labelling for indication, dosing, contraindications, and safety information; this regulatory record does not convey clinical evidence of efficacy or comparative benefit.

Plain-language summary

FDA approval of a fixed-dose combination syrup; this is a regulatory action confirming manufacturing and quality standards, not a clinical efficacy determination.

Reported figures

Quoted from the source exactly as published.

Promethazine hydrochloride concentration6.25 mg/5 mL

Dextromethorphan hydrobromide concentration15 mg/5 mL

Approval date2026-03-12

Clinical bottom line

Caveats

This is a regulatory approval record; no clinical trial data, efficacy evidence, or comparative outcomes are reported.
No information on indication, dosing regimen, patient population, contraindications, or adverse event profile is provided in this record.
Approval of the ANDA does not constitute a clinical efficacy determination or statement of comparative advantage over other formulations.

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 clinical trial design present.

Directness

insufficient

Record does not report clinical outcomes or comparators.

Consistency

insufficient

Single approval action; no comparative evidence provided.

Risk of bias

insufficient

Regulatory record; clinical trial methodology not described.

Sample adequacy

insufficient

No patient population or sample size reported in approval record.

Source abstract

Drugs@FDA record for application ANDA218264. This is a regulatory action record, not a clinical study. Brand name: PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE. Active ingredient: PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE. Sponsor: HETERO LABS LTD III. Submission type: ORIG (original application). Approval status date: 2026-03-12. Products: PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, SYRUP, ORAL, DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML + PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML.

Follow from this

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

Hetero Labs LTD IIIPromethazine Hydrochloride AND Dextromethorphan Hydrobromide