Clindamycin Hydrochloride · Regulatory label update

FDA supplemental approval: Clindamycin Hydrochloride (Labeling)

U.S. Food and Drug Administration · August 11, 2026

Regulatory Update Why this matters to you Expert discussion

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

AI Summary

The FDA approved a supplemental application for labeling changes to clindamycin hydrochloride capsules (150 mg and 300 mg strengths) from Aurobindo Pharma on 11 August 2026. This is a regulatory action document that does not contain clinical trial results, safety data, or efficacy comparisons.

What was studied

Regulatory label update.

Key findings

Supplemental approval granted for labeling of clindamycin hydrochloride 150 mg and 300 mg oral capsules Applicant: Aurobindo Pharma; ANDA number 065442

Safety

This record does not contain clinical trial results, efficacy data, or safety study outcomes. Applicant: Aurobindo Pharma; ANDA number 065442

Who this may help

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

Plain-language summary

FDA supplemental approval of labeling for an existing generic drug; no clinical efficacy or safety data presented.

Reported figures

Quoted from the source exactly as published.

Approval date2026-08-11

Dose strengths approved150 mg and 300 mg base equivalent

Caveats

This record does not contain clinical trial results, efficacy data, or safety study outcomes.
Labeling supplement only; no new preclinical or clinical evidence reported.
Specific labeling changes are not detailed in this regulatory summary.

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; no clinical study design reported.

Directness

insufficient

Labeling change only; no clinical outcome data.

Consistency

insufficient

Single regulatory record; no comparative data.

Risk of bias

insufficient

Not applicable to labeling submission.

Sample adequacy

insufficient

No clinical trial or patient population studied.

Source abstract

Drugs@FDA record for application ANDA065442. This is a regulatory action record, not a clinical study. Brand name: CLINDAMYCIN HYDROCHLORIDE. Active ingredient: CLINDAMYCIN HYDROCHLORIDE. Sponsor: AUROBINDO PHARMA. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-08-11. Products: CLINDAMYCIN HYDROCHLORIDE, CAPSULE, ORAL, CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE; CLINDAMYCIN HYDROCHLORIDE, CAPSULE, ORAL, CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE.

Follow from this

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

Clindamycin HydrochlorideAurobindo Pharma