Application 022428
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MOXEZA | MOXIFLOXACIN HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.5% BASE | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0065-0006 | MOXEZA | moxifloxacin hydrochloride | Alcon Laboratories, Inc. | NDA | Current |
| 0065-0006 | MOXEZA | moxifloxacin hydrochloride | Alcon Laboratories, Inc. | NDA | Current |
| 0065-0006 | MOXEZA | moxifloxacin hydrochloride | Alcon Laboratories, Inc. | NDA | Current |
| 0065-0006 | MOXEZA | moxifloxacin hydrochloride | Alcon Laboratories, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 68355 | SUPPL | 2021-08-12 |
| 68350 | SUPPL | 2021-08-12 |
| 47294 | SUPPL | 2017-02-23 |
| 47270 | SUPPL | 2017-02-21 |
| 38703 | SUPPL | 2012-09-18 |
| 7384 | SUPPL | 2012-09-18 |
| 29724 | SUPPL | 2011-10-20 |
| 24305 | ORIG | 2011-06-07 |
| 22020 | ORIG | 2011-06-07 |
| 38702 | ORIG | 2010-11-26 |
| 7383 | ORIG | 2010-11-26 |
| 53349 | ORIG | 1900-01-01 |
| 53348 | ORIG | 1900-01-01 |
| 53347 | ORIG | 1900-01-01 |