Application 022033
- Type
- NDA
- Sponsor
- JAZZ PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LUVOX CR | FLUVOXAMINE MALEATE | CAPSULE, EXTENDED RELEASE;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | LUVOX CR | FLUVOXAMINE MALEATE | CAPSULE, EXTENDED RELEASE;ORAL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 46797 | SUPPL | 2017-01-11 |
| 46796 | SUPPL | 2017-01-11 |
| 46720 | SUPPL | 2017-01-06 |
| 6737 | SUPPL | 2014-07-24 |
| 38115 | SUPPL | 2014-07-23 |
| 38114 | SUPPL | 2012-12-04 |
| 29117 | SUPPL | 2012-12-04 |
| 23693 | ORIG | 2012-02-13 |
| 29116 | SUPPL | 2011-05-11 |
| 29115 | SUPPL | 2011-05-11 |
| 6736 | SUPPL | 2011-05-11 |
| 16808 | SUPPL | 2011-05-09 |
| 16807 | SUPPL | 2011-05-09 |
| 16806 | SUPPL | 2011-05-09 |
| 38113 | SUPPL | 2009-03-17 |
| 6735 | SUPPL | 2009-02-27 |
| 24234 | ORIG | 2008-08-11 |
| 21913 | ORIG | 2008-08-11 |
| 16805 | ORIG | 2008-03-05 |
| 6734 | ORIG | 2008-03-04 |