Application 207609
- Type
- ANDA
- Sponsor
- HI TECH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LOTEPREDNOL ETABONATE | LOTEPREDNOL ETABONATE | SUSPENSION/DROPS;OPHTHALMIC | 0.5% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50383-265 | Loteprednol Etabonate | Loteprednol Etabonate | Hi-Tech Pharmacal Co., Inc. | ANDA | Current |
| 50383-265 | Loteprednol Etabonate | Loteprednol Etabonate | Hi-Tech Pharmacal Co., Inc. | ANDA | Current |
| 50383-265 | Loteprednol Etabonate | Loteprednol Etabonate | Hi-Tech Pharmacal Co., Inc. | ANDA | Current |
| 50383-265 | Loteprednol Etabonate | Loteprednol Etabonate | Akorn | ANDA | Current |
| 50383-265 | Loteprednol Etabonate | Loteprednol Etabonate | Hi-Tech Pharmacal Co., Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 58816 | ORIG | 2019-05-21 |