Application 204031
- Type
- NDA
- Sponsor
- MALLINCKRODT INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | XARTEMIS XR | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 325MG;7.5MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 23635-115 | Xartemis | oxycodone hydrochloride and acetaminophen | SpecGx LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 55665 | SUPPL | 2018-09-28 |
| 55664 | SUPPL | 2018-09-28 |
| 55553 | SUPPL | 2018-09-21 |
| 55552 | SUPPL | 2018-09-21 |
| 55551 | SUPPL | 2018-09-21 |
| 55550 | SUPPL | 2018-09-21 |
| 46431 | SUPPL | 2016-12-21 |
| 46300 | SUPPL | 2016-12-20 |
| 40344 | SUPPL | 2015-03-17 |
| 10285 | SUPPL | 2015-03-13 |
| 43453 | ORIG | 2014-04-18 |
| 19515 | ORIG | 2014-03-13 |
| 10284 | ORIG | 2014-03-13 |