Gatifloxacin
These highlights do not include all the information needed to use GATIFLOXACIN OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for GATIFLOXACIN OPHTHALMIC SOLUTION.GATIFLOXACIN ophthalmic solution, 0.5% for topical ophthalmic useInitial U.S. Approval: 1999
Approved
Approval ID
9e6fcd14-1fee-493f-811c-e18cbfbee65b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 31, 2021
Manufacturers
FDA
Sandoz Inc
DUNS: 005387188
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 Code61314-672
Application NumberANDA204227
Product Classification
M
Marketing Category
C73584
G
Generic Name
gatifloxacin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateApril 20, 2016
FDA Product Classification
INGREDIENTS (7)
BENZALKONIUM CHLORIDEInactive
Quantity: 0.5 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT
GATIFLOXACINActive
Quantity: 5 mg in 1 mL
Code: L4618BD7KJ
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT