FdaApplication
NDA 020897
Identifiers
- fda_app_no: NDA020897
Properties
| Property | Value |
|---|---|
| applicant_name | JANSSEN PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 1998-12-16 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DITROPAN XL | OXYBUTYNIN CHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
| DITROPAN XL | OXYBUTYNIN CHLORIDE | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
| DITROPAN XL | OXYBUTYNIN CHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
3 products