Gatifloxacin
These highlights do not include all the information needed to use Gatifloxacin Ophthalmic Solution, 0.5% safely and effectively. See full prescribing information for Gatifloxacin Ophthalmic Solution, 0.5%. Gatifloxacin Ophthalmic Solution, 0.5% Initial U.S. Approval: 1999
Approved
Approval ID
ce8409ee-a8a2-4943-b1b5-1ae7fdc9d50b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 9, 2016
Manufacturers
FDA
LUPIN LIMITED
DUNS: 675923163
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 Code57297-435
Application NumberANDA202653
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gatifloxacin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMay 9, 2016
FDA Product Classification
INGREDIENTS (7)
GATIFLOXACINActive
Quantity: 5 mg in 1 mL
Code: L4618BD7KJ
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT