FdaApplication
NDA 021589
Identifiers
- fda_app_no: NDA021589
Properties
| Property | Value |
|---|---|
| applicant_name | UCB INC |
| application_type | NDA |
| approval_date | 2003-10-30 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| KEMSTRO | BACLOFEN | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING;ORAL |
| KEMSTRO | BACLOFEN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING;ORAL |
2 products