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
NDC Product Code68682-299
Application NumberNDA020583
Marketing CategoryC73605
Route of AdministrationOPHTHALMIC
Effective DateMay 1, 2020
Generic Nameloteprednol etabonate
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