Glipizide · Regulatory label update

FDA supplemental approval: Glipizide (Manufacturing (CMC))

U.S. Food and Drug Administration · March 30, 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 manufacturing (CMC) changes to glipizide tablets (5 mg and 10 mg oral formulations) manufactured by Watson Labs Teva on 30 March 2026. This is a regulatory action record documenting approval of manufacturing or chemistry/manufacturing/controls changes to an existing generic drug product; it does not report clinical trial results, comparative efficacy, or safety data.

What was studied

Regulatory label update.

Key findings

Supplemental approval granted for glipizide 5 mg tablets (oral) on 2026-03-30 Supplemental approval granted for glipizide 10 mg tablets (oral) on 2026-03-30

Safety

This is a manufacturing approval record; no clinical trial data, efficacy, safety outcomes, or comparative information is included.

Who this may help

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

Plain-language summary

FDA supplemental approval for manufacturing changes to an established generic drug; does not contain clinical efficacy or safety data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-03-30

Submission typeSupplement (SUPPL)

Submission classManufacturing (CMC)

Caveats

This is a manufacturing approval record; no clinical trial data, efficacy, safety outcomes, or comparative information is included.
The record does not specify what manufacturing or CMC changes were approved.
No information on bioavailability, bioequivalence, or clinical performance is provided.
This action applies only to the manufacturer Watson Labs Teva and the specified formulations; generalizability to other manufacturers or formulations is not addressed.

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, not a clinical study.

Directness

insufficient

Record documents manufacturing approval only; no clinical outcomes reported.

Consistency

insufficient

Single regulatory action; no comparative or replication data provided.

Risk of bias

insufficient

Not applicable to manufacturing change approval.

Sample adequacy

insufficient

No patient sample or clinical data in this record.

Source abstract

Drugs@FDA record for application ANDA074223. This is a regulatory action record, not a clinical study. Brand name: GLIPIZIDE. Active ingredient: GLIPIZIDE. Sponsor: WATSON LABS TEVA. Submission type: SUPPL (supplement). Submission class: Manufacturing (CMC). Approval status date: 2026-03-30. Products: GLIPIZIDE, TABLET, ORAL, GLIPIZIDE 5MG; GLIPIZIDE, TABLET, ORAL, GLIPIZIDE 10MG.

Follow from this

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

GlipizideWatson Labs Teva