LOTEMAX
LOTEMAX® loteprednol etabonate ophthalmic suspension, 0.5%
Approved
Approval ID
e7ae762f-5e0b-4f64-9323-8f44db2c0b4c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 5, 2010
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4278
Application NumberNDA020583
Product Classification
M
Marketing Category
C73594
G
Generic Name
loteprednol etabonate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMarch 25, 2011
FDA Product Classification
INGREDIENTS (8)
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
LOTEPREDNOL ETABONATEActive
Quantity: 5 mg in 1 mL
Code: YEH1EZ96K6
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT