Doxycycline Hyclate · Regulatory label update

FDA supplemental approval: Doxycycline Hyclate (Labeling)

U.S. Food and Drug Administration · April 9, 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 record documenting FDA approval of a supplemental labeling change for doxycycline hyclate delayed-release tablets (75 mg and 100 mg base) by IMPAX Labs, approved 9 April 2026. The record does not contain clinical trial results, efficacy data, or safety findings; it is an administrative action only.

What was studied

Regulatory label update.

Key findings

Safety

This record does not contain clinical trial results, efficacy data, safety summaries, or the specific labeling changes approved.

Who this may help

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

Plain-language summary

FDA supplemental approval for labeling changes to doxycycline hyclate delayed-release tablets; regulatory action without clinical trial data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-04-09

Product strengths75 mg and 100 mg base equivalent

Caveats

This record does not contain clinical trial results, efficacy data, safety summaries, or the specific labeling changes approved.
No information on population studied, sample size, or comparative benefit is reported.
The nature and rationale for the labeling supplement are not disclosed in this regulatory record.

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 study design applicable.

Directness

insufficient

Labeling supplement; does not report clinical outcomes.

Consistency

insufficient

Single regulatory action; no comparative data provided.

Risk of bias

insufficient

Regulatory record does not address trial methodology or bias.

Sample adequacy

insufficient

No clinical study population or sample size 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 ANDA090505. This is a regulatory action record, not a clinical study. Brand name: DOXYCYCLINE HYCLATE. Active ingredient: DOXYCYCLINE HYCLATE. Sponsor: IMPAX LABS INC. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-04-09. Products: DOXYCYCLINE HYCLATE, TABLET, DELAYED RELEASE, ORAL, DOXYCYCLINE HYCLATE EQ 75MG BASE; DOXYCYCLINE HYCLATE, TABLET, DELAYED RELEASE, ORAL, DOXYCYCLINE HYCLATE EQ 100MG BASE.

Follow from this

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

Impax LabsDoxycycline Hyclate