---
brand_name: "AVANDAMET"
generic_name: "METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE"
slug: "metformin-hydrochloride-rosiglitazone-maleate"
canonical_url: "https://medichelpline.com/drug-index/metformin-hydrochloride-rosiglitazone-maleate"
content_type: "drug_monograph"
route: "ORAL"
drug_class: "General Medications"
fda_updated_at: "2017-04-05T00:00:00.000Z"
license: "Drugs@FDA Public Domain / Informational Use"
---
# AVANDAMET (METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE)
## Clinical Monograph Metadata
- **Canonical URL:** https://medichelpline.com/drug-index/metformin-hydrochloride-rosiglitazone-maleate
- **Generic / Active Ingredient:** METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
- **Brand Name:** AVANDAMET
- **Administration Route:** ORAL
- **Pharmacological Class:** General Medications
- **FDA Data Timestamp:** 2017-04-05T00:00:00.000Z
## Primary Indication & Clinical Use
Review priority: 901 REQUIRED Marketing status: Discontinued
## Monograph Summary

Approval overview AVANDAMET is listed in Drugs@FDA under application 021410 (NDA). Review priority: 901 REQUIRED Marketing status: Discontinued Active ingredient METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE Form and strength TABLET;ORAL - 500MG;EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor SB PHARMCO Submission history Latest submission status date: 2017-04-05 00:00:00. Submission type: SUPPL.

## Primary Sources & FDA Regulatory Records
- [Drugs@FDA Primary Database](https://www.accessdata.fda.gov/scripts/cder/daf/) (Reference Slug: `metformin-hydrochloride-rosiglitazone-maleate`)
## Navigation
- [← Back to Drug Index Hub](https://medichelpline.com/drug-index.md)
## Medical & Regulatory Disclaimer

> [!CAUTION]
> MedicHelpline content is structured for research, educational, and professional discovery purposes. It does not constitute individual medical advice, clinical diagnosis, or treatment recommendations.
> Always verify dosing, contraindications, and regulatory alerts against official product labeling and primary regulatory sources before clinical decision-making.