FdaApplication
NDA 021123
Identifiers
- fda_app_no: NDA021123
Properties
| Property | Value |
|---|---|
| applicant_name | JANSSEN PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 2001-08-15 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ULTRACET | ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE | 325MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
1 product