Metformin hydrochloride; rosiglitazone maleate
Metformin hydrochloride; rosiglitazone maleate: 1 brand, 1 generic; first approved Oct 10, 2002; generic available.
Generic available — 1 ANDA application approved.
Brand (NDA) products
AVANDAMETRLDSB PHARMCONDA 02141020035 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 500MG;EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | ORAL | Discontinued | — |
| 500MG;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | ORAL | Discontinued | — |
| 500MG;EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | ORAL | Discontinued | — |
| 1GM;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | ORAL | Discontinued | — |
| 1GM;EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | ORAL | Discontinued | — |
Generic (ANDA) products (1)
TEVAANDA 07733720145 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 500MG;EQ 2MG BASE | TABLET | ORAL | Discontinued | — |
| 500MG;EQ 4MG BASE | TABLET | ORAL | Discontinued | — |
| 1GM;EQ 2MG BASE | TABLET | ORAL | Discontinued | — |
| 1GM;EQ 4MG BASE | TABLET | ORAL | Discontinued | — |
| 500MG;EQ 1MG BASE | TABLET | ORAL | Discontinued | — |
Listed patents
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
Approvals span 2002–2017 across 2 FDA applications.
Metformin hydrochloride; rosiglitazone maleate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
