Alrex
Alrex (loteprednol etabonate ophthalmic suspension, 0.2%) STERILE OPHTHALMIC SUSPENSION
Approved
Approval ID
21c76da0-50a1-41c0-91b8-8cc4dcc27f60
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 31, 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
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24208-353
Application NumberNDA020803
Product Classification
M
Marketing Category
C73594
G
Generic Name
loteprednol etabonate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMarch 31, 2022
FDA Product Classification
INGREDIENTS (9)
LOTEPREDNOL ETABONATEActive
Quantity: 2 mg in 1 mL
Code: YEH1EZ96K6
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Quantity: 0.1 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT