FdaApplication
NDA 007337
Identifiers
- fda_app_no: NDA007337
Properties
| Property | Value |
|---|---|
| applicant_name | ENDO OPERATIONS LTD |
| application_type | NDA |
| approval_date | 2005-08-05 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PERCODAN | ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE | 325MG;4.5MG;0.38MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| PERCODAN | ASPIRIN; OXYCODONE HYDROCHLORIDE | 325MG;4.8355MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| PERCODAN-DEMI | ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE | 325MG;2.25MG;0.19MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
3 products