Gatifloxacin
These highlights do not include all the information needed to use GATIFLOXACIN safely and effectively. See full prescribing information for GATIFLOXACIN.GATIFLOXACIN ophthalmic solution, 0.5% for topical ophthalmic useInitial U.S. Approval: 1999
Approved
Approval ID
14312de6-67d4-4de2-854c-ef764090dd83
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 11, 2022
Manufacturers
FDA
Akorn
DUNS: 117696873
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Gatifloxacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50383-189
Application NumberANDA203189
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gatifloxacin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMarch 11, 2022
FDA Product Classification
INGREDIENTS (7)
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
GATIFLOXACIN ANHYDROUSActive
Quantity: 5 mg in 1 mL
Code: 81485Y3A9A
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT