Application 021493
- Type
- NDA
- Sponsor
- ALLERGAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZYMAR | GATIFLOXACIN | SOLUTION/DROPS;OPHTHALMIC | 0.3% | Yes | Yes |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 47683 | SUPPL | 2017-03-24 |
| 47632 | SUPPL | 2017-03-22 |
| 54221 | SUPPL | 2017-03-21 |
| 37070 | SUPPL | 2015-05-27 |
| 5542 | SUPPL | 2015-05-22 |
| 51933 | SUPPL | 2009-05-19 |
| 51932 | SUPPL | 2009-05-19 |
| 51931 | SUPPL | 2009-05-19 |
| 51930 | SUPPL | 2009-05-19 |
| 51929 | SUPPL | 2009-05-19 |
| 37069 | SUPPL | 2005-06-21 |
| 27929 | SUPPL | 2005-06-21 |
| 15599 | SUPPL | 2005-06-21 |
| 5541 | SUPPL | 2005-06-21 |
| 42192 | ORIG | 2005-05-02 |
| 37068 | ORIG | 2003-04-01 |
| 27928 | ORIG | 2003-04-01 |