Doxepin Hydrochloride · Regulatory approval

FDA approval: Doxepin Hydrochloride

U.S. Food and Drug Administration · April 28, 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 U.S. FDA approval record for a generic doxepin hydrochloride 5% topical cream formulation (ANDA213919) by SUN PHARMA CANADA, approved 28 April 2026. The record documents regulatory authorization but does not include clinical trial data, efficacy outcomes, or safety results. Clinicians should refer to the established safety and efficacy profile of doxepin topical formulations and the approved package insert for prescribing guidance.

What was studied

Regulatory approval. Intervention: Doxepin hydrochloride 5% cream, topical formulation.

Key findings

Doxepin hydrochloride 5% cream (topical) approved via ANDA 213919 on 28 April 2026

Safety

This is a regulatory approval record and does not report clinical trial results, efficacy data, safety outcomes, or adverse event frequencies. Clinical safety and efficacy rest on the established profile of doxepin topical formulations; approval signifies manufacturing and bioequivalence compliance only.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

FDA approval of a generic topical doxepin cream formulation; a regulatory action that confirms manufacturing and bioequivalence standards but does not report clinical trial outcomes.

Study design

As stated by the source record.

InterventionDoxepin hydrochloride 5% cream, topical formulation

Reported figures

Quoted from the source exactly as published.

Application numberANDA213919

Approval date2026-04-28

Concentration5%

FormulationCream, topical

Caveats

This is a regulatory approval record and does not report clinical trial results, efficacy data, safety outcomes, or adverse event frequencies.
The record does not provide comparative data with the reference listed drug or other topical doxepin formulations.
No information on bioequivalence study design, sample size, or acceptance criteria is disclosed in this approval record.
Clinical safety and efficacy rest on the established profile of doxepin topical formulations; approval signifies manufacturing and bioequivalence compliance only.

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 record; no clinical study design reported.

Directness

insufficient

Approval record does not describe clinical endpoints or outcomes.

Consistency

insufficient

Single regulatory action; no comparative data or meta-analysis.

Risk of bias

insufficient

Regulatory record does not disclose trial methodology or bias assessment.

Sample adequacy

insufficient

No sample size or clinical population data reported in approval record.

Source abstract

Drugs@FDA record for application ANDA213919. This is a regulatory action record, not a clinical study. Brand name: DOXEPIN HYDROCHLORIDE. Active ingredient: DOXEPIN HYDROCHLORIDE. Sponsor: SUN PHARMA CANADA. Submission type: ORIG (original application). Approval status date: 2026-04-28. Products: DOXEPIN HYDROCHLORIDE, CREAM, TOPICAL, DOXEPIN HYDROCHLORIDE 5%.

Follow from this

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

Doxepin HydrochlorideSUN Pharma Canada