FLUOROMETHOLONE
FLUOROMETHOLONE ophthalmic suspension, USP 0.1% sterile
Approved
Approval ID
af59c420-789d-4c05-b3fc-c3f855bcac24
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 21, 2020
Manufacturers
FDA
Pacific Pharma, Inc.
DUNS: 877645267
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fluorometholone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60758-880
Application NumberNDA016851
Product Classification
M
Marketing Category
C73605
G
Generic Name
fluorometholone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateNovember 13, 2023
FDA Product Classification
INGREDIENTS (10)
fluorometholoneActive
Quantity: 1 mg in 1 mL
Code: SV0CSG527L
Classification: ACTIB
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
sodium phosphate, dibasicInactive
Code: GR686LBA74
Classification: IACT
sodium phosphate, monobasicInactive
Code: 3980JIH2SW
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT