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
NDC Product Code60758-880
Application NumberNDA016851
Marketing CategoryC73605
Route of AdministrationOPHTHALMIC
Effective DateNovember 13, 2023
Generic Namefluorometholone
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