FdaApplication
NDA 021202
Identifiers
- fda_app_no: NDA021202
Properties
| Property | Value |
|---|---|
| applicant_name | EMD SERONO INC |
| application_type | NDA |
| approval_date | 2000-10-13 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| GLUCOPHAGE XR | METFORMIN HYDROCHLORIDE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
| GLUCOPHAGE XR | METFORMIN HYDROCHLORIDE | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
2 products