FdaApplication
NDA 021692
Identifiers
- fda_app_no: NDA021692
Properties
| Property | Value |
|---|---|
| applicant_name | VALEANT PHARMACEUTICALS NORTH AMERICA LLC |
| application_type | NDA |
| approval_date | 2005-09-08 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ULTRAM ER | TRAMADOL HYDROCHLORIDE | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
| ULTRAM ER | TRAMADOL HYDROCHLORIDE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
| ULTRAM ER | TRAMADOL HYDROCHLORIDE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
3 products