Application 205777
- Type
- NDA
- Sponsor
- PURDUE PHARMA LP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TARGINIQ | NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 5MG;10MG | Yes | No |
| 002 | TARGINIQ | NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 10MG;20MG | Yes | No |
| 003 | TARGINIQ | NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 20MG;40MG | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 55667 | SUPPL | 2018-09-28 |
| 55666 | SUPPL | 2018-09-28 |
| 55549 | SUPPL | 2018-09-21 |
| 55548 | SUPPL | 2018-09-21 |
| 55547 | SUPPL | 2018-09-21 |
| 55546 | SUPPL | 2018-09-21 |
| 48587 | SUPPL | 2017-05-31 |
| 46576 | SUPPL | 2016-12-29 |
| 46437 | SUPPL | 2016-12-21 |
| 46324 | SUPPL | 2016-12-20 |
| 45454 | SUPPL | 2016-10-03 |
| 32723 | SUPPL | 2016-04-22 |
| 24127 | ORIG | 2015-11-04 |
| 10501 | SUPPL | 2015-07-07 |
| 44598 | ORIG | 2015-06-30 |
| 23002 | ORIG | 2014-08-27 |
| 32722 | SUPPL | 2014-08-20 |
| 32721 | ORIG | 2014-07-23 |
| 19684 | ORIG | 2014-07-23 |