Loteprednol Etabonate is a Ophthalmic Suspension/ Drops in the Human Prescription Drug category. It is labeled and distributed by Hi-tech Pharmacal Co., Inc.. The primary component is Loteprednol Etabonate.
| Product ID | 50383-265_54e60a43-16f1-4bae-823e-3b8e040ffd28 |
| NDC | 50383-265 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Loteprednol Etabonate |
| Generic Name | Loteprednol Etabonate |
| Dosage Form | Suspension/ Drops |
| Route of Administration | OPHTHALMIC |
| Marketing Start Date | 2019-04-18 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA207609 |
| Labeler Name | Hi-Tech Pharmacal Co., Inc. |
| Substance Name | LOTEPREDNOL ETABONATE |
| Active Ingredient Strength | 5 mg/mL |
| Pharm Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2019-04-18 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA207609 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2019-04-18 |
| Marketing Category | ANDA |
| Application Number | ANDA207609 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-04-18 |
| Marketing End Date | 2019-11-18 |
| Marketing Category | ANDA |
| Application Number | ANDA207609 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2019-04-18 |
| Marketing Category | ANDA |
| Application Number | ANDA207609 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2019-04-18 |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 17478-830 | Loteprednol Etabonate | Loteprednol Etabonate |
| 24208-508 | Loteprednol Etabonate | loteprednol etabonate |
| 50383-265 | Loteprednol Etabonate | Loteprednol Etabonate |
| 62756-232 | Loteprednol Etabonate | Loteprednol Etabonate |
| 68682-299 | Loteprednol Etabonate | loteprednol etabonate |
| 24208-353 | Alrex | loteprednol etabonate |
| 71571-333 | Eysuvis | loteprednol etabonate |
| 71571-121 | Inveltys | loteprednol etabonate |
| 24208-299 | LOTEMAX | loteprednol etabonate |
| 24208-443 | Lotemax | loteprednol etabonate |
| 24208-503 | LOTEMAX | loteprednol etabonate |
| 24208-507 | Lotemax SM | loteprednol etabonate |