Zylet is a Ophthalmic Suspension/ Drops in the Human Prescription Drug category. It is labeled and distributed by Bausch & Lomb Incorporated. The primary component is Loteprednol Etabonate; Tobramycin.
| Product ID | 24208-358_0e91d40c-b306-46b0-90b2-bc015f0f86c5 |
| NDC | 24208-358 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Zylet |
| Generic Name | Loteprednol Etabonate And Tobramycin |
| Dosage Form | Suspension/ Drops |
| Route of Administration | OPHTHALMIC |
| Marketing Start Date | 2004-12-14 |
| Marketing Category | NDA / NDA |
| Application Number | NDA050804 |
| Labeler Name | Bausch & Lomb Incorporated |
| Substance Name | LOTEPREDNOL ETABONATE; TOBRAMYCIN |
| Active Ingredient Strength | 5 mg/mL; mg/mL |
| Pharm Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2004-12-14 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA |
| Application Number | NDA050804 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2004-12-14 |
| Marketing End Date | 2013-01-25 |
| Marketing Category | NDA |
| Application Number | NDA050804 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2004-12-14 |
| Marketing Category | NDA |
| Application Number | NDA050804 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2004-12-14 |
| Marketing Category | NDA |
| Application Number | NDA050804 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2004-12-14 |
| Ingredient | Strength |
|---|---|
| LOTEPREDNOL ETABONATE | 5 mg/mL |
| SPL SET ID: | 3dd9b060-5355-404d-bdf1-09ee8b52a9f5 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ZYLET 78112937 3002481 Live/Registered |
BAUSCH & LOMB INCORPORATED 2002-03-06 |