FdaApplication
NDA 021700
Identifiers
- fda_app_no: NDA021700
Properties
| Property | Value |
|---|---|
| applicant_name | SB PHARMCO PUERTO RICO INC |
| application_type | NDA |
| approval_date | 2005-11-23 |
Products (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| AVANDARYL | GLIMEPIRIDE; ROSIGLITAZONE MALEATE | 1MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| AVANDARYL | GLIMEPIRIDE; ROSIGLITAZONE MALEATE | 2MG;8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| AVANDARYL | GLIMEPIRIDE; ROSIGLITAZONE MALEATE | 4MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| AVANDARYL | GLIMEPIRIDE; ROSIGLITAZONE MALEATE | 4MG;8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| AVANDARYL | GLIMEPIRIDE; ROSIGLITAZONE MALEATE | 2MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
5 products