Application 202916
- Type
- ANDA
- Sponsor
- AKORN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.5% BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 17478-519 | Moxifloxacin | Moxifloxacin | Akorn, Inc. | ANDA | Current |
| 17478-519 | Moxifloxacin | Moxifloxacin | Akorn | ANDA | Current |
| 17478-519 | Moxifloxacin | Moxifloxacin | Akorn, Inc. | ANDA | Current |
| 50090-5279 | Moxifloxacin | Moxifloxacin | A-S Medication Solutions | ANDA | Current |
| 55700-657 | Moxifloxacin | Moxifloxacin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 72189-334 | MOXIFLOXACIN | MOXIFLOXACIN | Direct Rx | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 10135 | ORIG | 2013-11-20 |