FdaApplication
NDA 021574
Identifiers
- fda_app_no: NDA021574
Properties
| Property | Value |
|---|---|
| applicant_name | ANDRX LABS LLC |
| application_type | NDA |
| approval_date | 2004-04-27 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| FORTAMET | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE;ORAL |
| FORTAMET | METFORMIN HYDROCHLORIDE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
2 products