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
NDC Product Code24208-358
Application NumberNDA050804
Marketing CategoryC73594
Route of AdministrationOPHTHALMIC
Effective DateApril 30, 2022
Generic Nameloteprednol etabonate and tobramycin
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