FdaApplication
NDA 204031
Identifiers
- fda_app_no: NDA204031
Properties
| Property | Value |
|---|---|
| applicant_name | MALLINCKRODT INC |
| application_type | NDA |
| approval_date | 2014-03-11 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| XARTEMIS XR | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
1 product