Application 216130
- Type
- ANDA
- Sponsor
- MANKIND PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OFLOXACIN | OFLOXACIN | SOLUTION/DROPS;OTIC | 0.3% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68071-2894 | ofloxacin | ofloxacin otic | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2910 | ofloxacin | ofloxacin otic | NuCare Pharmceuticals,Inc. | ANDA | Current |
| 70756-609 | ofloxacin | ofloxacin otic | Lifestar Pharma LLC | ANDA | Current |
| 70756-609 | ofloxacin | ofloxacin otic | Lifestar Pharma LLC | ANDA | Current |
| 70756-609 | ofloxacin | ofloxacin otic | Lifestar Pharma LLC | ANDA | Current |
| 70756-610 | ofloxacin | ofloxacin otic | Lifestar Pharma LLC | ANDA | Current |
| 70756-610 | ofloxacin | ofloxacin otic | Lifestar Pharma LLC | ANDA | Current |
| 70756-610 | ofloxacin | ofloxacin otic | Lifestar Pharma LLC | ANDA | Current |