Zylet
These highlights do not include all the information needed to use ZYLET safely and effectively. See full prescribing information for ZYLET.ZYLET (loteprednol etabonate and tobramycin ophthalmic suspension) 0.5%/0.3%, for topical ophthalmic use Initial U.S. Approval: 2004
Approved
Approval ID
3dd9b060-5355-404d-bdf1-09ee8b52a9f5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 30, 2022
Manufacturers
FDA
Bausch & Lomb Incorporated
DUNS: 196603781
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
loteprednol etabonate and tobramycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24208-358
Application NumberNDA050804
Product Classification
M
Marketing Category
C73594
G
Generic Name
loteprednol etabonate and tobramycin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateApril 30, 2022
FDA Product Classification
INGREDIENTS (10)
LOTEPREDNOL ETABONATEActive
Quantity: 5 mg in 1 mL
Code: YEH1EZ96K6
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TOBRAMYCINActive
Quantity: 3 mg in 1 mL
Code: VZ8RRZ51VK
Classification: ACTIB
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT