Application 202867
- Type
- ANDA
- Sponsor
- LUPIN LTD
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 |
|---|---|---|---|---|---|
| 68180-422 | Moxifloxacin | Moxifloxacin | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-422 | Moxifloxacin | Moxifloxacin | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-422 | Moxifloxacin | Moxifloxacin | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 72189-321 | MOXIFLOXACIN | MOXIFLOXACIN | Direct Rx | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 10124 | ORIG | 2014-09-08 |