Application 021199
- Type
- NDA
- Sponsor
- SANTEN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | QUIXIN | LEVOFLOXACIN | SOLUTION/DROPS;OPHTHALMIC | 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 14624 | SUPPL | 2014-12-10 |
| 4617 | SUPPL | 2014-12-04 |
| 36328 | SUPPL | 2005-04-12 |
| 27044 | SUPPL | 2005-04-12 |
| 14623 | SUPPL | 2005-04-12 |
| 4616 | SUPPL | 2005-04-12 |
| 42015 | ORIG | 2004-03-24 |
| 36327 | SUPPL | 2002-06-04 |
| 27043 | SUPPL | 2002-06-04 |
| 36326 | SUPPL | 2002-04-18 |
| 4615 | SUPPL | 2002-04-18 |
| 36325 | ORIG | 2000-08-18 |
| 4614 | ORIG | 2000-08-18 |