Lotemax SM is a Ophthalmic Gel in the Human Prescription Drug category. It is labeled and distributed by Bausch & Lomb Incorporated. The primary component is Loteprednol Etabonate.
| Product ID | 24208-507_3cf15719-d911-4dda-be1e-6cea35831743 |
| NDC | 24208-507 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Lotemax SM |
| Generic Name | Loteprednol Etabonate |
| Dosage Form | Gel |
| Route of Administration | OPHTHALMIC |
| Marketing Start Date | 2019-02-25 |
| Marketing Category | NDA / NDA |
| Application Number | NDA208219 |
| Labeler Name | Bausch & Lomb Incorporated |
| Substance Name | LOTEPREDNOL ETABONATE |
| Active Ingredient Strength | 4 mg/g |
| Pharm Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2019-02-25 |
| NDC Exclude Flag | N |
| Sample Package? | Y |
| Marketing Category | NDA |
| Application Number | NDA208219 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2019-02-25 |
| Marketing Category | NDA |
| Application Number | NDA208219 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-02-25 |
| Marketing Category | NDA |
| Application Number | NDA208219 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-02-25 |
| Ingredient | Strength |
|---|---|
| LOTEPREDNOL ETABONATE | 3.8 mg/g |
| SPL SET ID: | 6f9477b5-699f-4d3b-b9a6-0cc238266237 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 24208-507 | Lotemax SM | 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 |
| 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 |