FdaApplication
NDA 021615
Identifiers
- fda_app_no: NDA021615
Properties
| Property | Value |
|---|---|
| applicant_name | JANSSEN PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 2005-04-01 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| RAZADYNE ER | GALANTAMINE HYDROBROMIDE | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE;ORAL |
| RAZADYNE ER | GALANTAMINE HYDROBROMIDE | EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE;ORAL |
| RAZADYNE ER | GALANTAMINE HYDROBROMIDE | EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE;ORAL |
3 products