Metformin Hydrochloride; Repaglinide

Sold as Prandimet. Every FDA application for this active ingredient: 1 branded and 1 generic.

As of Nov 15, 2026, FDA lists 2 applications for Metformin Hydrochloride; Repaglinide (sold as Prandimet), first approved Jun 23, 2008, with 0 new uses approved and 0 published complete response letters.

First approved: Jun 23, 2008
Applications: 2
New uses approved: 0
Complete response letters: 0

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
A Study to Investigate the Effects of Multiple Doses of Rezatapopt on the Pharmacokinetics of Metformin, Rosuvastatin, Repaglinide, and Midazolam in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation.TP53 Y220C Mutation, Advanced Solid Tumors · PMV Pharmaceuticals, Inc	Phase 1	Recruiting	Jan 28, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jun 23, 2008	PrandimetNDA 22386 · New combination	Novo Nordisk Inc	11	Discontinued
Jul 15, 2015	Repaglinide And Metformin HydrochlorideANDA 200624	Lupin	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA