Loteprednol Etabonate
Loteprednol Etabonate Ophthalmic Suspension 0.5%
Approved
Approval ID
f9edfd73-e1b1-44e4-8e7c-90b0c2fa204d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 1, 2020
Manufacturers
FDA
Oceanside Pharmaceuticals
DUNS: 832011691
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 Code68682-299
Application NumberNDA020583
Product Classification
M
Marketing Category
C73605
G
Generic Name
loteprednol etabonate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMay 1, 2020
FDA Product Classification
INGREDIENTS (9)
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
LOTEPREDNOL ETABONATEActive
Quantity: 5 mg in 1 mL
Code: YEH1EZ96K6
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Quantity: 0.1 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT