ALREX
ALREX loteprednol etabonate ophthalmic suspension, 0.2%
Approved
Approval ID
95188fb4-03b6-46ac-a601-41cb82ebde40
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 10, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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
NDC Product Code54868-4277
Application NumberNDA020803
Marketing CategoryC73594
Route of AdministrationOPHTHALMIC
Effective DateSeptember 10, 2012
Generic Nameloteprednol etabonate
INGREDIENTS (9)
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
LOTEPREDNOL ETABONATEActive
Quantity: 2 mg in 1 mL
Code: YEH1EZ96K6
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT