FdaApplication
NDA 020281
Identifiers
- fda_app_no: NDA020281
Properties
| Property | Value |
|---|---|
| applicant_name | JANSSEN PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 1995-03-03 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ULTRAM | TRAMADOL HYDROCHLORIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| ULTRAM | TRAMADOL HYDROCHLORIDE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
2 products