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Application 022235
- Type
- NDA
- Sponsor
- JAZZ
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LUVOX | FLUVOXAMINE MALEATE | TABLET; ORAL | 25MG | Yes | No |
| 002 | LUVOX | FLUVOXAMINE MALEATE | TABLET; ORAL | 50MG | Yes | No |
| 003 | LUVOX | FLUVOXAMINE MALEATE | TABLET; ORAL | 100MG | Yes | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 44176 | ORIG | 2012-02-13 |
| 43839 | ORIG | 2011-04-01 |
| 44710 | ORIG | 2009-09-03 |
| 21965 | ORIG | 2009-09-03 |
| 7076 | ORIG | 2008-05-22 |
| 17109 | ORIG | 2008-04-23 |