Doxepin Hydrochloride · Regulatory label update

FDA supplemental approval: Doxepin Hydrochloride (Labeling)

U.S. Food and Drug Administration · July 16, 2026

Regulatory Update Why this matters to you Expert discussion

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

AI Summary

This is an FDA supplemental approval action for labeling changes to doxepin hydrochloride capsules (10 mg, 25 mg, 75 mg, and 100 mg strengths) submitted by Mylan Pharmaceuticals. The record documents a regulatory decision dated 16 July 2026 but contains no clinical trial results, efficacy data, or safety comparisons.

What was studied

Regulatory label update.

Key findings

Safety

This record documents a regulatory labeling approval; it does not contain clinical trial results, efficacy data, safety outcomes, or comparative evidence.

Who this may help

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

Plain-language summary

FDA supplemental approval of labeling changes for doxepin hydrochloride; does not contain clinical trial data or efficacy evidence.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-07-16

Doxepin strength 110 mg

Doxepin strength 225 mg

Doxepin strength 375 mg

Doxepin strength 4100 mg

Caveats

This record documents a regulatory labeling approval; it does not contain clinical trial results, efficacy data, safety outcomes, or comparative evidence.
The specific labeling changes approved are not detailed in this record.
No study population, sample size, or clinical endpoints are reported.

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 action record; no clinical study design present.

Directness

insufficient

Labeling approval; no direct clinical evidence reported.

Consistency

insufficient

Single regulatory action; no comparative data provided.

Risk of bias

insufficient

Not applicable to regulatory labeling approval action.

Sample adequacy

insufficient

No clinical sample or trial data reported.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Drugs@FDA record for application ANDA070791. This is a regulatory action record, not a clinical study. Brand name: DOXEPIN HYDROCHLORIDE. Active ingredient: DOXEPIN HYDROCHLORIDE. Sponsor: MYLAN PHARMS INC. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-07-16. Products: DOXEPIN HYDROCHLORIDE, CAPSULE, ORAL, DOXEPIN HYDROCHLORIDE EQ 75MG BASE; DOXEPIN HYDROCHLORIDE, CAPSULE, ORAL, DOXEPIN HYDROCHLORIDE EQ 10MG BASE; DOXEPIN HYDROCHLORIDE, CAPSULE, ORAL, DOXEPIN HYDROCHLORIDE EQ 100MG BASE; DOXEPIN HYDROCHLORIDE, CAPSULE, ORAL, DOXEPIN HYDROCHLORIDE EQ 25MG BASE.

Follow from this

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

Doxepin HydrochlorideMylan Pharms