Flarex
FLAREX (fluorometholone acetate ophthalmic suspension) 0.1% Sterile
Approved
Approval ID
19918ea5-8568-44d6-b8ee-7b2197cee85c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 10, 2023
Manufacturers
FDA
Eyevance Pharmaceuticals
DUNS: 080876046
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fluorometholone acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71776-100
Application NumberNDA019079
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluorometholone acetate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 10, 2023
FDA Product Classification
INGREDIENTS (10)
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FLUOROMETHOLONE ACETATEActive
Quantity: 1 mg in 1 mL
Code: 9I50C3I3OK
Classification: ACTIB