FdaApplication
NDA 021410
Identifiers
- fda_app_no: NDA021410
Properties
| Property | Value |
|---|---|
| applicant_name | SB PHARMCO PUERTO RICO INC |
| application_type | NDA |
| approval_date | 2002-10-10 |
Products (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| AVANDAMET | METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE | 1GM;EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| AVANDAMET | METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE | 500MG;EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| AVANDAMET | METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE | 1GM;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| AVANDAMET | METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE | 500MG;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| AVANDAMET | METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE | 500MG;EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
5 products